Document text
Page 1 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044953
Page 2 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044954
Page 3 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061020]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044955
Page 4 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044956
Page 5 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044957
Page 6 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044958
Page 7 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIABETES TYPE 2]
Start Date: Aug/21/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CAUTERIZED ULCERS ON DUODENUM]
Start Date: Feb/9/2008
Ongoing: NO
End Date:
Feb/9/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BOWEL BLOCKAGE]
Start Date: Apr/1/2008
Ongoing: NO
End Date:
Apr/1/2008
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BOWEL BLOCKAGE REMOVAL]
Start Date: Apr/1/2008
Ongoing: NO
End Date:
Apr/1/2008
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044959
Page 8 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CATARACT SURGERY]
Start Date: Aug/UNK/2010
Ongoing: NO
End Date:
Aug/UNK/2010
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEART ATTACK]
Start Date: Dec/UNK/1989
Ongoing: NO
End Date:
Dec/UNK/1989
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEART ATTACK]
Start Date: Mar/25/2004
Ongoing: NO
End Date:
Mar/UNK/2004
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CARDIAC STENT PLACEMENT]
Start Date: Mar/25/2004
Ongoing: NO
End Date:
Mar/25/2004
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044960
Page 9 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEART ATTACK]
Start Date: Mar/UNK/2017
Ongoing: NO
End Date:
Mar/UNK/2017
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CARDIAC STENT PLACEMENT]
Start Date: Mar/UNK/2017
Ongoing: NO
End Date:
Mar/UNK/2017
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/1989
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PLANTAR FACIITIS OF RIGHT FOOT]
Start Date: UNK/UNK/2016
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FLATULENCE]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044961
Page 10 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POLYNEUROPATHY, DIABETIC BILATERAL FEET]
Start Date: UNK/UNK/2016
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[XEROSIS CUTIS]
Start Date: UNK/UNK/2015
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2000
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2018
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANAL FISSURE]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044962
Page 11 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FACTOR 5 LIDEN]
Start Date: /1944
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEEP VEIN THROMBOPHLEBITIS RIGHT LEG]
Start Date: UNK/UNK/1983
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT BACK PAIN]
Start Date: UNK/UNK/1990
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RECURRENT BILATERAL LOWER EXTREMITIES EDEMA]
Start Date: UNK/UNK/2000
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BASAL CELL CARCINOMA, RECURRENT, MULTIPLE LOCATIONS]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044963
Page 12 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ATHEROSCLEROSIS]
Start Date: Dec/UNK/1989
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MITRAL VALVE PROLAPSE]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
Aug/27/2020
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RECURRENT PEPTIC ULCER]
Start Date: UNK/UNK/1980
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TRANSIENT ISCHEMIC ATTACK]
Start Date: Jan/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TRANSIENT ISCHEMIC ATTACK]
Start Date: Jul/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044964
Page 13 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CARDIOVASCULAR ACCIDENT]
Start Date: Mar/6/2019
Ongoing: NO
End Date:
Mar/UNK/2019
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT BUNDLE BRANCH BLOCK]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044965
Page 14 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [177.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [24.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044966
Page 15 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226866]
3.Randomization Group: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044967
Page 16 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLX0FL]
5.bSample ID [BLX0FM]
5.cSample ID [BLX0FN]
5.dSample ID [BLZ8B7]
5.eSample ID [BLZ8B8]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044968
Page 17 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHV2MM]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044969
Page 18 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 11:32
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
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044970
Page 19 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044971
Page 20 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044972
Page 21 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044973
Page 22 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044974
Page 23 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044975
Page 24 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044976
Page 25 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044977
Page 26 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044978
Page 27 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044979
Page 28 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044980
Page 29 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044981
Page 30 of 187
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044982
Page 31 of 187
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044983
Page 32 of 187
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044984
Page 33 of 187
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044985
Page 34 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044986
Page 35 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044987
Page 36 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044988
Page 37 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044989
Page 38 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044990
Page 39 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044991
Page 40 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044992
Page 41 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044993
Page 42 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044994
Page 43 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044995
Page 44 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/16/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044996
Page 45 of 187
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/16/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044997
Page 46 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044998
Page 47 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0044999
Page 48 of 187
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 CORONARY ARTERY OCCLUSI
ON Aug/25/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 DYSPNEA ON EXERTION Aug/25/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE E
VENT 3 ANGINA Aug/21/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
4.ADVERSE E
VENT 4 NON-ST ELEVATED MYOCARD
IAL INFARCTION Aug/25/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
5.ADVERSE E
VENT 5 MITRAL VALVE REGURGITATI
ON Aug/25/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045000
Page 49 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[CORONARY ARTERY OCCLUSION]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
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:
[CORONARY ATHEROSCLEROSIS]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045001
Page 50 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020336034]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045002
Page 51 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[DYSPNEA ON EXERTION]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 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:
[CORONARY ATHEROSCLEROSIS]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045003
Page 52 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045004
Page 53 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[ANGINA]
4.Start Date Time: Aug/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 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:
[CORONARY ATHEROSCLEROSIS]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045005
Page 54 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045006
Page 55 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[NON-ST ELEVATED MYOCARDIAL INFARCTION]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CORONARY ARTHEROSCLEROSIS]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045007
Page 56 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045008
Page 57 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[MITRAL VALVE REGURGITATION]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PROGRESSION OF MYXOMATOUS MITRAL VALVE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045009
Page 58 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045010
Page 59 of 187
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045011
Page 60 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045012
Page 61 of 187
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045013
Page 62 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045014
Page 63 of 187
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045015
Page 64 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045016
FDA-CBER-2021-5683-0045017
Page 66 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045018
FDA-CBER-2021-5683-0045019
Page 68 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045020
Page 69 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045021
Page 70 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045022
Page 71 of 187
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045023
Page 72 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045024
Page 73 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045025
Page 74 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045026
Page 75 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045027
Page 76 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045028
Page 77 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045029
Page 78 of 187
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045030
Page 79 of 187
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045031
Page 80 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045032
Page 81 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/16/2020
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045033
Page 82 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045034
Page 83 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/16/2020
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045035
Page 84 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045036
Page 85 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
James Peterson Approved Nov-13-2020 17:23:03 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045037
Page 86 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormSep-17-2020 12:15:54 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
FormSep-16-2020 11:29:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)due to subject change in health they no longer
meet criterion as of 16Sep2020 and have been
discontinued from the trial
FormSep-16-2020 11:02:06 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
FormAug-12-2020 18:11:50 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045038
Page 87 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-06-2020 12:20:42 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045039
Page 88 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-06-2020 12:20:42 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045040
Page 89 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-06-2020 12:20:42 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045041
Page 90 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
James Peterson Approved Nov-13-2020 17:23:03 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Colby Bostock N/A Nov-12-2020 14:34:27 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Nov-09-2020 13:09:24 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Nov-06-2020 12:20:42 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Oct-13-2020 11:59:30 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045042
Page 91 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Oct-13-2020 09:45:14 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-22-2020 17:54:42 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Sep-22-2020 11:53:11 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-21-2020 17:16:15 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045043
Page 92 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lindsey Bevan N/A Sep-21-2020 10:58:01 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-18-2020 18:40:30 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Sep-18-2020 14:56:24 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-17-2020 12:21:11 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Sep-17-2020 12:13:51 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-16-2020 21:47:42 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045044
Page 93 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey Bevan N/A Sep-16-2020 10:48:24 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Sep-10-2020 21:45:14 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045045
Page 94 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 18:10:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020 18:10:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045046
Page 95 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 18:11:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045047
Page 96 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 18:10:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10061020Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 18:10:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 18:11:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 18:11:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020 18:11:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
WHITEInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045048
Page 97 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 13:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Laurie Hawes
(pfe hawesl01)Query 1: Closed Response satisfies
query
Nov-06-2020 12:20:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Changed data per
query
Nov-06-2020 01:09:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R
(pfe rb01)Query 1: Opened At the time
disposition treatment
CRF was completed,
visit 2 was due based
on protocol defined
window period. In
case visit 2 was not
performed, please
complete visit 2 date
of CRF with form
level comment as
NOT DONE and
leave all other CRFs
blank.
Aug-12-2020 18:11:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily Wilcox
(pfe.ewilcox)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045049
Page 98 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 12:15:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Criterion Description:Changed Information
Sep-16-2020 11:02:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Crite
rion
Desc
ripti
on:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination pla
n, laboratory tests, lifestyle co
nsiderations, and other study
proceduresInitial Entry
1.a Description of Inclusion Criterion Not Met
Date Location User Value Reason
Sep-18-2020 04:18:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Closed Not Applicable added
Sep-17-2020 12:15:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Sep-17-2020 12:15:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Changed Information
Sep-17-2020 00:29:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Opened PDQ: Inclusion criteria
have been added,
vaccination details
present.
Inclusion/Exclusion is
expected only for
Screen Failure and
subjects randomized in
error. Please add Form
level comment “Not
Applicable” if
Incl/Excl was added in
error or confirm.
Sep-16-2020 11:02:20
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
Participants who are willing and ablInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045050
Page 99 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan) e to comply with all scheduled visit
s, vaccination plan, laboratory tests,
lifestyle considerations, and other st
udy procedures
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045051
Page 100 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 18:11:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 18:11:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 18:11:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045052
Page 101 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 09:27:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:DIABETES TY
PE 2
Start Date: Aug/21/1995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:27:58
(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
Aug-13-2020 09:27:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
DIABETES TYPE 2Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 09:27:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Aug/21/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 09:27:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045053
Page 102 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020 14:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ty Henry
(pfe.thenry)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:CAUTERIZED ULCE
RS ON DUODENUM
Start Date: Feb/9/2008
Ongoing: NO
End Date:
Feb/9/2020Stop date provided.
Aug-13-2020 09:28:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:CAUTERIZED ULCE
RS ON DUODENUM
Start Date: Feb/9/2008
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045054
Page 103 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:28:22
(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
Aug-13-2020 09:28:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CAUTERIZED ULCERS ON DUO
DENUMInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 09:28:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Feb/9/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020 18:42:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Aug-18-2020 14:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Stop date provided.
Aug-18-2020 14:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ty Henry
(pfe.thenry)Data Entry:
NO
End Date:
Feb/9/2020Stop date provided.
Aug-15-2020 22:17:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Opened CAUTERIZED
ULCERS ON
DUODENUM : As
this is a procedure,
please can you
provide a stop date
Aug-13-2020 09:28:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045055
Page 104 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c
Date Location User Value Reason
Aug-13-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:BOWEL BLOCK
AGE
Start Date: Apr/1/2008
Ongoing: NO
End Date:
Apr/1/2008Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:28:53
(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
Aug-13-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BOWEL BLOCKAGEInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Apr/1/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Apr/1/2008Initial Entry
1.d
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045056
Page 105 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-13-2020 09:29:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:BOWEL BLOCKAG
E REMOVAL
Start Date: Apr/1/2008
Ongoing: NO
End Date:
Apr/1/2008Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:29:16
(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
Aug-13-2020 09:29:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BOWEL BLOCKAGE REMOVALInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 09:29:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Apr/1/2008Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 09:29:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Apr/1/2008Initial Entry
1.e
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045057
Page 106 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:CATARACT SUR
GERY
Start Date: Aug/UNK/2010
Ongoing: NO
End Date:
Aug/UNK/201
0Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:29:38
(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
Aug-13-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CATARACT SURGERYInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Aug/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Aug/UNK/2010Initial Entry
1.f
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045058
Page 107 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 09:30:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH Number
:6
Medical History T
erm:HEART ATTA
CK
Start Date: Dec/UNK/1989
Ongoing: NO
End Date:
Dec/UNK/1
989Transcription Error
Aug-13-2020 09:30:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:HEART ATTA
CH
Start Date: Dec/UNK/1989
Ongoing: NO
End Date:
Dec/UNK/1
989Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045059
Page 108 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:30:00
(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
Aug-13-2020 09:30:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HEART ATTACKTranscription Error
Aug-13-2020 09:30:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HEART ATTACHInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 09:30:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Dec/UNK/1989Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 09:30:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Dec/UNK/1989Initial Entry
1.g
Date Location User Value Reason
Aug-13-2020 09:30:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:HEART ATTA
CK
Start Date: Mar/25/2004Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045060
Page 109 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
Mar/UNK/20
04
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:30:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:30:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HEART ATTACKInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 09:30:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Mar/25/2004Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 09:30:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Mar/UNK/2004Initial Entry
1.h
Date Location User Value Reason
Aug-13-2020 09:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:CARDIAC STENT P
LACEMENT
Start Date: Mar/25/2004Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045061
Page 110 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
Mar/25/2004
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CARDIAC STENT PLACEMENTInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 09:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Mar/25/2004Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 09:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Mar/25/2004Initial Entry
1.i
Date Location User Value Reason
Aug-13-2020 09:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:HEART ATTA
CK
Start Date: Mar/UNK/2017Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045062
Page 111 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
Mar/UNK/20
17
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HEART ATTACKInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045063
Page 112 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.i Start Date:
Date Location User Value Reason
Aug-13-2020 09:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Mar/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020 09:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Mar/UNK/2017Initial Entry
1.j
Date Location User Value Reason
Aug-13-2020 09:32:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:CARDIAC STENT P
LACEMENT
Start Date: Mar/UNK/2017
Ongoing: NO
End Date:
Mar/UNK/2017Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045064
Page 113 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.j Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:32:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:32:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CARDIAC STENT PLACEMENTInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-13-2020 09:32:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Mar/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-13-2020 09:32:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Mar/UNK/2017Initial Entry
1.k
Date Location User Value Reason
Aug-13-2020 09:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:CORONARY ARTE
RY DISEASE
Start Date: UNK/UNK/1989
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045065
Page 114 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.k Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CORONARY ARTERY DISEASEInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-13-2020 09:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1989Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-13-2020 09:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-13-2020 09:33:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Hist
ory Term:PLANTAR FACIITIS
OF RIGHT FOOT
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045066
Page 115 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.l Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:33:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:33:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
PLANTAR FACIITIS OF RIGHT F
OOTInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-13-2020 09:33:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2016Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-13-2020 09:33:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-13-2020 09:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Ter
m:FLATULENC
E
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045067
Page 116 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.m Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
FLATULENCEInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-13-2020 09:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2008Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-13-2020 09:33:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-13-2020 09:34:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:POLYNEUROPATHY,
DIABETIC BILATER
AL FEET
Start Date
:UNK/UNK/2016
Ongoing: YESTranscription Error
Aug-13-2020 09:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:14Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045068
Page 117 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical H
istory Ter
m:POLYNEUROPATHY,
DIABETIC BIALTER
AL FEET
Start Date
:UNK/UNK/2016
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:34:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
POLYNEUROPATHY, DIABETIC
BILATERAL FEETTranscription Error
Aug-13-2020 09:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
POLYNEUROPATHY, DIABETIC
BIALTERAL FEETInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-13-2020 09:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2016Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-13-2020 09:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-13-2020 09:36:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045069
Page 118 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical History Te
rm:XEROSIS CU
TIS
Start Date: UNK/UNK/20
15
Ongoing: YES
1.o Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:36:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:36:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
XEROSIS CUTISInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-13-2020 09:36:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2015Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-13-2020 09:36:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-13-2020 09:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16
Medical Histo
ry Term:HYPERCHOLEST
EROLEMIA
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045070
Page 119 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.p Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-13-2020 09:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2000Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-13-2020 09:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-13-2020 09:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:HYPERTENSI
ON
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045071
Page 120 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.q Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
HYPERTENSIONInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-13-2020 09:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2018Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-13-2020 09:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Te
rm:ANAL FISSU
RE
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045072
Page 121 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.r Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
ANAL FISSUREInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2018Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Aug-13-2020 09:37:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History Te
rm:FACTOR 5 LID
EN
Start Date: /1944
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045073
Page 122 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.s Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:37:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Aug-18-2020 13:40:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ty Henry
(pfe.thenry)Query 1: Answered Not exclusionary per
investigator.
Aug-17-2020 02:51:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Opened There is a Med Hx
entry of Factor V
Leiden, please
confirm if pt meets
exclusions criteria
#10.
Aug-13-2020 09:37:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
FACTOR 5 LIDENInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-13-2020 09:37:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
/1944Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-13-2020 09:37:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045074
Page 123 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 09:37:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:20
Medical Hi
story Term
:DEEP VEIN THROMB
OPHLEBITIS RIGHT
LEG
Start Date: UNK/UNK/1983
Ongoing: YESInitial Entry
1.t Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:37:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:37:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
DEEP VEIN THROMBOPHLEBITI
S RIGHT LEGInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-13-2020 09:37:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1983Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-13-2020 09:37:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Aug-13-2020 09:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 21
Medical History T
erm:LEFT BACK P
AINInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045075
Page 124 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Start Date: UNK/UNK/199
0
Ongoing: YES
1.u Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
LEFT BACK PAINInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-13-2020 09:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1990Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-13-2020 09:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Aug-13-2020 09:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:22
Medical
History T
erm:RECURRENT BILATER
AL LOWER EXTREMIT
IES EDEMA
Start Dat
e:UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045076
Page 125 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.v Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECURRENT BILATERAL LOWE
R EXTREMITIES EDEMAInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-13-2020 09:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2000Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-13-2020 09:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Aug-18-2020 14:00:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ty Henry
(pfe.thenry)Data Entry:
Line/M
H Numb
er:23
Medical
History
Term:BASAL CELL CARCIN
OMA, RECURRENT, M
ULTIPLE LOCATIONS
Start Da
te:UNK/UNK/2010
Ongoing
:YESUpdated info.
Aug-13-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N 23Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045077
Page 126 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
umber:
Medical His
tory Term:BASAL CELL CARCI
NOMA, RECURREN
T
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045078
Page 127 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.w Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:42:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Aug-18-2020 14:00:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Updated info.
Aug-18-2020 14:00:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ty Henry
(pfe.thenry)Data Entry:
BASAL CELL CARCINOMA, REC
URRENT, MULTIPLE LOCATION
SUpdated info.
Aug-15-2020 22:08:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Opened Please could you also
provide the location
(Eg; neck, Arm, Leg)
of the Basal Cell
Carcinoma
Aug-13-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BASAL CELL CARCINOMA, REC
URRENTInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-13-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2010Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-13-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.x
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045079
Page 128 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Sep-16-2020 15:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:24
Medical Hist
ory Term:CORONARY ATHE
ROSCLEROSIS
Start Date: Dec/UNK/1989
Ongoing: YESInitial Entry
1.x Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CORONARY ATHEROSCLEROSISInitial Entry
1.x Start Date:
Date Location User Value Reason
Sep-16-2020 15:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Dec/UNK/1989Initial Entry
1.x Ongoing:
Date Location User Value Reason
Sep-16-2020 15:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.y
Date Location User Value Reason
Sep-16-2020 15:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:25Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045080
Page 129 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histo
ry Term:MITRAL VALVE P
ROLAPSE
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
Aug/27/2020
1.y Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
MITRAL VALVE PROLAPSEInitial Entry
1.y Start Date:
Date Location User Value Reason
Sep-16-2020 15:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1989Initial Entry
1.y Ongoing:
Date Location User Value Reason
Sep-16-2020 15:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Aug/27/2020Initial Entry
1.z
Date Location User Value Reason
Sep-16-2020 15:13:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:26Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045081
Page 130 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histo
ry Term:RECURRENT PEP
TIC ULCER
Start Date: UNK/UNK/1980
Ongoing: YES
1.z Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:13:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:13:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECURRENT PEPTIC ULCERInitial Entry
1.z Start Date:
Date Location User Value Reason
Sep-16-2020 15:13:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1980Initial Entry
1.z Ongoing:
Date Location User Value Reason
Sep-16-2020 15:13:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Sep-16-2020 15:14:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:27
Medical Hist
ory Term:TRANSIENT ISCHE
MIC ATTACK
Start Date: Jan/UNK/2016Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045082
Page 131 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/2016
1.aa Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:14:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:14:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
TRANSIENT ISCHEMIC ATTACKInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045083
Page 132 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.aa Start Date:
Date Location User Value Reason
Sep-16-2020 15:14:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Jan/UNK/2016Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Sep-16-2020 15:14:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.ab
Date Location User Value Reason
Sep-16-2020 15:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:28
Medical Hist
ory Term:TRANSIENT ISCHE
MIC ATTACK
Start Date: Jul/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045084
Page 133 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.ab Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
TRANSIENT ISCHEMIC ATTACKInitial Entry
1.ab Start Date:
Date Location User Value Reason
Sep-16-2020 15:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Jul/UNK/2018Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Sep-16-2020 15:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.ac
Date Location User Value Reason
Sep-16-2020 15:14:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:29
Medical Hist
ory Term:CARDIOVASCULA
R ACCIDENT
Start Date: Mar/6/2019
Ongoing: NO
End Date:
Mar/UNK/2019Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045085
Page 134 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.ac Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:14:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:14:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CARDIOVASCULAR ACCIDENTInitial Entry
1.ac Start Date:
Date Location User Value Reason
Sep-16-2020 15:14:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Mar/6/2019Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Sep-16-2020 15:14:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
Mar/UNK/2019Initial Entry
1.ad
Date Location User Value Reason
Sep-16-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:30
Medical Hist
ory Term:RIGHT BUNDLE B
RANCH BLOCK
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045086
Page 135 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.ad Line/MH Number:
Date Location User Value Reason
Sep-16-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RIGHT BUNDLE BRANCH BLOC
KInitial Entry
1.ad Start Date:
Date Location User Value Reason
Sep-16-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2017Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Sep-16-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045087
Page 136 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
177.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.0Initial Entry
7.a
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045088
Page 137 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 18:12:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045089
Page 138 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 18:13:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 18:13:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
226866Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045090
Page 139 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:13:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:13:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 07:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 05:13:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-12-2020 18:13:14
(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.
Aug-12-2020 18:13:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045091
Page 140 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 07:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BLX0FLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 07:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BLX0FLInitial Entry
5.b
Date Location User Value Reason
Aug-13-2020 07:47:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BLX0FMInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 07:47:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BLX0FMInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020 07:47:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BLX0FNInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 07:47:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BLX0FNInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020 07:48:10
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
Sample ID: BLZ8B7Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045092
Page 141 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan)
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 07:48:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BLZ8B7Initial Entry
5.e
Date Location User Value Reason
Aug-13-2020 07:48:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BLZ8B8Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 07:48:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BLZ8B8Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045093
Page 142 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:13:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:13:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 07:47:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 05:17:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-12-2020 18:13:25
(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.
Aug-12-2020 18:13:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045094
Page 143 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 07:47:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2MMInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 07:47:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2MMInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045095
Page 144 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Aug/12/2020 11:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045096
Page 145 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-12-2020 18:13:41
(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
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-12-2020 18:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045097
Page 146 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 18:13:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045098
Page 147 of 187
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 12:20:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-06-2020 12:20:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045099
Page 148 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Nov-13-2020
19:22:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
2: Clo
sedAuto closed by Validation
Check: VC_DS001_14_AN
Nov-13-2020
13:51:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query
2: Ans
weredCorrect per discussion with
DM
Nov-13-2020
12:57:28
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Josee Robillard
(pfe robilj01)Query
1: Clo
sedClosing as confirmed with
stats/spa that the dates are
correct as entered given the
scenario. SAE with a
resolution date of
27AUG2020 however
subject withdrawn due to
SAE and same time
withdrew consent on
16SEP2020 following
discussion with PI.
Nov-12-2020
23:56:43
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Gajanan Deshmukh
(pfe.deshmg08)Query
1: Rei
ssued:
Opene
dDM : Thanks for the
response. However, Date of
Completion/Discontinuation
/Death (16/Sep/2020) is still
not between AE start date
25AUG2020 and end date
27AUGP2020 which
causing withdrawal of the
study vaccine. Please
review and update.
Else,clarify.
Nov-12-2020
19:46:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
2: Op
enedDMW5372218;‘Treatment
Date of
Completion/Discontinuation
/Death' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045100
Page 149 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Follow-up eCRF. Please
clarify or correct.
Nov-12-2020
14:34:52
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Colby Bostock
(pfe.cbostock)Query
1: Ans
weredupdated edc
Nov-10-2020
19:04:17
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query
1: Op
enedThe discontinuation date of
16SEP2020 should be
relative to the AE causing
the the withdrawal of the
study vaccine, AE start
25AUG2020 and end
27AUGP2020. Please
adjust Discontinuation date.
Sep-16-2020
10:48:24
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data
Entry
:
Sep/1
6/202
0Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 10:48:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020 12:15:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Sep-17-2020 12:14:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-17-2020 12:14:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045101
Page 150 of 187
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-17-2020 12:14:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 12:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-17-2020 12:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Sep-17-2020 12:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
ADVERSE EVENTChanged Information
Sep-16-2020 10:48:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO LONGER MEETS ELIGIBILIT
Y CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-17-2020 12:15:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Changed Information
Sep-17-2020 12:14:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Adverse event 1Initial Entry
Sep-17-2020 12:14:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Changed Information
Sep-16-2020 10:48:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
No longer inclusion 2Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045102
Page 151 of 187
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-13-2020 13:51:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Sep/16/2020Changed Information
Nov-12-2020 23:52:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Nov-12-2020 14:36:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-12-2020 14:36:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Colby Bostock
(pfe.cbostock)Data Entry:
Aug/27/2020Changed Information
Nov-10-2020 19:04:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Opened The discontinuation
date of 16SEP2020
should be relative to
the AE causing the
the withdrawal of the
study vaccine, AE
start 25AUG2020 and
end 27AUGP2020.
Please adjust
Discontinuation date.
Sep-16-2020 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 11:15:37
(UTC-07:00) MountainACV0PFEINFP6000 Erica Weaver
(pfe.weavee01)Query 1: Closed Response satisfies
query
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045103
Page 152 of 187
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
Oct-13-2020 09:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-13-2020 09:45:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-13-2020 09:45:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-13-2020 09:45:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
ADVERSE EVENTChanged Information
Oct-13-2020 09:35:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver
(pfe.weavee01)Query 1: Opened As per AE form,
please update to
ADVERSE EVENT
if the AE caused
study discontinuation
and remove status on
item 4.
Sep-16-2020 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
NO LONGER MEETS ELIGIBIL
ITY CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-13-2020 09:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Changed Information
Sep-16-2020 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
No longer meets inclusion 2Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045104
Page 153 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045105
Page 154 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045106
Page 155 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045107
Page 156 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045108
Page 157 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-08-2020 14:30:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045109
Page 158 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-18-2020 14:56:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CORONARY ARTERY OCCLUSI
ONChanged Information
Sep-01-2020 04:31:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed reported under AER
2020336034
Aug-31-2020 11:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered SAE reported to Pfizer
per protocol
Aug-31-2020 05:00:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:WORSENING
CORONARY ARTERY
DISEASE(Onset
date:25Aug2020) is not
reported on SAE Report
Form but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event on
AE CRF.
Aug-28-2020 18:34:45
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
WORSENING CORONARY ARTInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045110
Page 159 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan) ERY DISEASE
4. Start Date Time:
Date Location User Value Reason
Sep-17-2020 17:23:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 2: Closed Response satisfies
query
Sep-16-2020 14:54:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 2: Answered SAE narrative
updated
Sep-12-2020 06:34:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 2: Opened Clinical_1) submit fu
SAE to reflect angina
duration (still reflects
2 wks). Onset date of
event needs to reflect
start of this
non-serious event of
angina. Update med
hx for baseline
angina. 2) RBBB in
narrative as previous
hx - update med hx.
Sep-06-2020 07:30:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Closed Response satisfies
query
Sep-03-2020 17:48:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered SAE updated with
information from
Medical Records
Sep-03-2020 09:01:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Reissued:Opened GPDCLIN: Angina
and SOB were added
with a start date of
21Aug2020 while the
SAE narrative reports
onset of angina 2
weeks prior to
hospitalization
(~12Aug2020). Please
reconcile and if
needed, please submit
a follow-up SAE form
with corrections.
Sep-02-2020 14:08:02
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanQuery 1: Answered Changed data per
query
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045111
Page 160 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan)
Sep-02-2020 06:16:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPDCLIN: Per SAE
narrative, subject
reported Angina that
started 2 weeks prior
to hospitalization on
25Aug2020. Please
confirm and if correct,
please add Angina as
a separate non-serious
AE with start/stop
dates and confirm
Inclusion criterion #3
was met.
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Aug/25/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date Time:
Aug/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 22:34:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed Query closed; will
follow for SAE
update with the
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045112
Page 161 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
requested COVID test
info
Oct-27-2020 16:20:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 4: Answered COVID testing not
performed. Follow-up
SAE form to be faxed
to the safety team
Oct-25-2020 19:26:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened COVID testing has
not been reported in
the SAE submitted to
safety. Please submit
a follow-up SAE
form [#2020336034]
to provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Sep-01-2020 04:31:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Aug-31-2020 23:50:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Thanks for response.
This will be managed
internally.
Aug-31-2020 15:36:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE
WORSENING
CORONARY
ARTERY DISEASE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-31-2020 15:36:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NOChanged Information
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045113
Page 162 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
YES
Other medically important seriou
s event
NO
Aug-31-2020 11:08:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered NO PLACE IN ECRF
FOR SERIOUS
ADVERSE EVENT
NUMBER:
2020336034
Aug-31-2020 01:07:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened For AE
WORSENING
CORONARY
ARTERY DISEASE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-28-2020 18:35:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-28-2020 18:35:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NOTranscription Error
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045114
Page 163 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
YES
Other medically important seriou
s event
NO
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please
review and update as
appropriate.
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
WORSENING
CORONARY
ARTERY DISEASE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Is this serious event life threateni
ng?Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045115
Page 164 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Aug-28-2020 18:35:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
CORONARY ATHEROSCLE
ROSISTranscription Error
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-17-2020
19:00:00
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Cl
osedAuto closed by
Validation Check:
VC_AE001_32
Sep-17-2020
12:15:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: A
nsweredChanged data per
query
Sep-17-2020
00:28:55
(UTC-07:00)
Mountain TimeACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: O
penedDMW4726011;The
Latest Action to
Study Treatment is
DRUG
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045116
Page 165 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) WITHDRAWN, but
the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Sep-16-2020
15:19:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry
:
DRUG WI
THDRAW
NNew Information
Aug-28-2020
18:34:45
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry
:
NOT APPL
ICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-03-2020 05:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed outcome updated in SDB to
recovered/resolved. issue
resolved
Sep-02-2020 06:03:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Candidate to check next SAE listing and
monitor update of outcome
Sep-01-2020 11:44:13 ACV0PFEINFP6000 Ty Henry Query 1: Answered Original value is correct.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045117
Page 166 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00) Mountain
Time (US & Canada)(pfe.thenry) Updated SAE form submitted.
Sep-01-2020 04:36:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020336034
,outcome was reported as
RECOVERING/RESOLVING
in SAE form
however,reported as
RECOVERED/RESOLVED
on AE CRF.Please confirm
correct outcome.If safety
update is required,please
submit ffup. AEM form
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-17-2020 12:14:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESChanged Information
Aug-28-2020 18:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-01-2020 04:31:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020336034Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045118
Page 167 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
DYSPNEA ON EXERTIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-21-2020 10:59:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
Gong
(pfe.gongq)Query 1: Closed Response satisfies
query
Sep-21-2020 10:58:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Sep-21-2020 10:58:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Aug/25/2020 UNK:UNKChanged Information
Sep-19-2020 19:06:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver
(pfe.weavee01)Query 1: Reissued:Opened GPDClin: In the SAE
report, this symptom
started from 25/Aug
/2020. If that is
correct, please make
the corresponding
revision here. Form is
unfrozen.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045119
Page 168 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-18-2020 12:33:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
Gong
(pfe.gongq)Query 1: Reissued:Candidate GPDClin: Please
unfreeze MHx
module, so the site
can revise the data.
Sep-18-2020 10:36:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: Answered Please unfreeze form
for correction
Sep-17-2020 18:58:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
Gong
(pfe.gongq)Query 1: Opened GPDClin: In the SAE
report, this symptom
started from 25/Aug
/2020. If that is
correct, please make
the corresponding
revision here.
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Aug/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date Time:
Aug/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
NOInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045120
Page 169 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan)
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-02-2020 15:58:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
CORONARY ATHEROSCLE
ROSISInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045121
Page 170 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-02-2020 14:07:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045122
Page 171 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
ANGINAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-19-2020 10:41:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 1: Closed Response satisfies
query
Sep-18-2020 10:37:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Confirm Correct
Sep-17-2020 17:47:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 1: Opened Clinical_as the date
of onset of this
overall event began
on 21 Aug, please
submit fu SAE form
to update the onset
date of the event in
the safety database.
The dates in the
clinical database do
not further updates
unless not correct.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045123
Page 172 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Aug/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date Time:
Aug/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-02-2020 15:58:59
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
NOT RELATEDInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045124
Page 173 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan) If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
CORONARY ATHEROSCLE
ROSIS
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-02-2020 14:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045125
Page 174 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-19-2020 10:42:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 1: Closed Clinical_per
discussion w CRA
confirmed that a
followup SAE form
was submitted based
on discussion w
investigator--
underlying dx updated
from worsening CAD
to coronary artery
occlusion.
Sep-18-2020 10:38:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered NSTEMI not
underlying cause for
SAE. FU SAE has
been submitted
Sep-17-2020 17:25:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 1: Reissued:Opened Clinical_appreciate the
confirmation. If the
coronary artery
occlusion is the
underlying diagnosis
for worsening CAD,
please update the SAE
term in a fu SAE form
and add to the AE log.
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045126
Page 175 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020 14:55:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered SAE narrative updated
Sep-12-2020 06:26:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Charu
Sabharwal
(pfe.sabhac)Query 1: Opened Clinical_In the SAE
narrative, 1) NSTEMI
not reported. Submit
FU SAE to include this
diagnosis/assess
seriousness if
underlying cause of
worsening CAD.
Update AE log
accordingly 2) MVR
assess for seriousness
and confirm new
diagnosis.
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NON-ST ELEVATED MYOCARDI
AL INFARCTIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Aug/25/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date Time:
Aug/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-16-2020 15:19:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
3Changed Information
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
4Initial Entry
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045127
Page 176 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-10-2020 06:28:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Sep-09-2020 14:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-09-2020 14:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
CORONARY ARTHEROSC
LEROSISNew Information
Sep-09-2020 07:18:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened please consider if AE
is related to Med Hx
condition Coronary
Artery Disease, or to
090177e196ae3d24\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045128
Page 177 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061020 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
SAE of Worsening
Coronary Artery
Disease
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-08-2020 14:29:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-10-2020 00:10:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Sep-09-2020 14:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-09-2020 14:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESTranscription Error
Sep-09-2020 07:33:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Please
clarify no
concomitant
medication was given
for this AE or update
as applicable.
Sep-08-2020 14:29:
…[truncated]