Document text
Page 1 of 259
***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: 10061052 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
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045647
Page 2 of 259
***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: 10061052 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/18/2020
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045648
Page 3 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061052]
2.Birth Date: /1984
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:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045649
Page 4 of 259
***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: 10061052 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/18/2020
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045650
Page 5 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045651
Page 6 of 259
***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: 10061052 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/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045652
Page 7 of 259
***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: 10061052 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:[dyshidroctic eczema]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIABETES MELITUS TYPE I]
Start Date: UNK/UNK/1989
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ERECTILE DYSFUNCTION]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ERYTHROMYCIN BASE INTOLERANCE]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045653
Page 8 of 259
***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: 10061052 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:[RECURRING COUGH]
Start Date: UNK/UNK/2014
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CALCIFIC TENDINITIS RIGHT HAND]
Start Date: Nov/3/2018
Ongoing: YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045654
Page 9 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [241.0]
3.Unit: LB
4.Height: [70.5]
5.Unit: in
6.Body Mass Index: [34.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045655
Page 10 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [53735]
3.Randomization Group: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045656
Page 11 of 259
***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: 10061052 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/18/2020
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 [BHV2TP]
5.bSample ID [BHV2TR]
5.cSample ID [BHV2TS]
5.dSample ID [BJ7LZW]
5.eSample ID [BJ7LZX]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045657
Page 12 of 259
***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: 10061052 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/18/2020
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 [BHV2NL]
5.bSample ID [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045658
Page 13 of 259
***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: 10061052 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/18/2020 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045659
Page 14 of 259
***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: 10061052 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 collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045660
Page 15 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Sep/8/2020
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045661
Page 16 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045662
Page 17 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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:
Sep/8/2020
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 [BCT8GZ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045663
Page 18 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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: Sep/8/2020 11:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045664
Page 19 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Oct/9/2020
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045665
Page 20 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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:
Oct/9/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BCT8C9]
5.bSample ID [BJ7M6S]
5.cSample ID [BJ7MCT]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045666
Page 21 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10061052 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 Sep/1/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045667
Page 22 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Colle
ctionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice T
ypeForm Instanc
e
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045668
Page 23 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045669
Page 24 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045670
Page 25 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045671
Page 26 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045672
Page 27 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045673
Page 28 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045674
Page 29 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045675
Page 30 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1. Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045676
Page 31 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045677
FDA-CBER-2021-5683-0045678
Page 33 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045679
FDA-CBER-2021-5683-0045680
Page 35 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045681
FDA-CBER-2021-5683-0045682
Page 37 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: OXYGENATION PARAMETERS
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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045683
Page 38 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045684
Page 39 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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.Start Date: //
6.Ongoing?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045685
FDA-CBER-2021-5683-0045686
Page 41 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045687
Page 42 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10061052 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 Sep/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045688
Page 43 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/23/2020
2.Date of First Symptom Started: Sep/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045689
Page 44 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045690
Page 45 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Colle
ctionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice T
ypeForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Done
Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045691
Page 46 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045692
Page 47 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
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: 10061052 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Protocol Deviation]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045693
Page 48 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10061052 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045694
Page 49 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045695
Page 50 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045696
Page 51 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045697
Page 52 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045698
Page 53 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045699
Page 54 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045700
Page 55 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045701
Page 56 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045702
Page 57 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045703
Page 58 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1. Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045704
Page 59 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045705
FDA-CBER-2021-5683-0045706
Page 61 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045707
FDA-CBER-2021-5683-0045708
Page 63 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045709
FDA-CBER-2021-5683-0045710
Page 65 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS
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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045711
Page 66 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045712
Page 67 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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.Start Date: //
6.Ongoing?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045713
FDA-CBER-2021-5683-0045714
Page 69 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045715
Page 70 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Oct/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045716
Page 71 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 10061052 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:
Oct/27/2020
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 [BH244G]
5.bSample ID [BSJPKT]
5.cSample ID [BJ7MGM]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045717
Page 72 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045718
Page 73 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045719
Page 74 of 259
***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: 10061052 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 :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045720
Page 75 of 259
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045721
Page 76 of 259
***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: 10061052 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:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045722
Page 77 of 259
***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: 10061052 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 [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045723
Page 78 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1. DELETED ADVERS
E EVENT 1 VOMITTING Sep/18/2020
UNK:UNK NO
End Date Time:
Sep/18/2020 UN
K:UNK
Repeating
Pages
2. ADVERS
E EVENT 2 Exposure During P
artner Pregnancy Jan/1/2021 U
NK:UNK YES Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045724
Page 79 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[VOMITTING ]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/18/2020 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
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Page 80 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[FOOD DIDN'T SIT WELL ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045726
Page 81 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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)[Exposure During Partner Pregnancy]
4.Start Date Time: Jan/1/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
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
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045727
Page 82 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:
[Stopped condoms]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045728
Page 83 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045729
Page 84 of 259
***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: 10061052 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[ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045730
Page 85 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart D
ateForm Instan
ce
1.1 VACCINATION
S NO Influenza vac
cine Oct/6/2
020 Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045731
Page 86 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[Influenza vaccine]
5.Date: Oct/6/2020
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Page 87 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045733
Page 88 of 259
***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: 10061052 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?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045734
Page 89 of 259
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045735
Page 90 of 259
***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: 10061052 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?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045736
FDA-CBER-2021-5683-0045737
Page 92 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045738
Page 93 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045739
Page 94 of 259
***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: 10061052 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:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045740
Page 95 of 259
***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: 10061052 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?
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045741
Page 96 of 259
***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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045742
Page 97 of 259
***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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045743
Page 98 of 259
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Feb/2/2021
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045744
Page 99 of 259
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045745
Page 100 of 259
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045746
Page 101 of 259
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045747
Page 102 of 259
***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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045748
Page 103 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Feb/15/2021
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045749
Page 104 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/15/2021
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045750
Page 105 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045751
Page 106 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045752
Page 107 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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:
Feb/15/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBM9R]
5.bSample ID [BSB8SB]
5.cSample ID [BJ7MZ9]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045753
Page 108 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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:
Feb/15/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBCJ4]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045754
Page 109 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/15/2021 10:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045755
Page 110 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 Mar/9/2021
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045756
Page 111 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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:
Mar/9/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBCLD]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045757
Page 112 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/9/2021 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045758
Page 113 of 259
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045759
Page 114 of 259
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045760
Page 115 of 259
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045761
Page 116 of 259
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045762
Page 117 of 259
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045763
Page 118 of 259
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 10061052 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: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045764
Page 119 of 259
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045765
Page 120 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/9/2020
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045766
Page 121 of 259
***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: 10061052 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
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045767
Page 122 of 259
***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: 10061052 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 Mar-11-2021 14:18:05 (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.
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045768
Page 123 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-18-2020 14:13:32 (UTC-07:00)
Mountain Time (US & Canada)Maddie Grote
(pfe.mgrote)Not Applicable
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045769
Page 124 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045770
Page 125 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045771
Page 126 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045772
Page 127 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045773
Page 128 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045774
Page 129 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045775
Page 130 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045776
Page 131 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045777
Page 132 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045778
Page 133 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Oct-22-2020 14:30:47 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045779
Page 134 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Feb-19-2021 10:32:03 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045780
Page 135 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormFeb-15-2021 11:26:18 (UTC-07:00)
Mountain Time (US & Canada)Ashley Bragg
(pfe.abragg)Not Applicable
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045781
Page 136 of 259
***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: 10061052 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 Mar-11-2021 14:18:05 (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.
Bradley
Young N/A Feb-08-2021 15:42:59 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James
Peterson Approved Oct-29-2020 14:10:19 (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 Oct-28-2020 16:21:11 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045782
Page 137 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
James
Peterson Approved Oct-28-2020 15:50:50 (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 Oct-26-2020 10:24:30 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James
Peterson Approved Oct-23-2020 12:25:33 (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 Oct-22-2020 14:19:31 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045783
Page 138 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
James
Peterson Approved Oct-21-2020 15:16:17 (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.
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045784
Page 139 of 259
***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: 10061052 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-18-2020
14:06:39 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020
14:06:39 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045785
Page 140 of 259
***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: 10061052 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-18-2020
14:06:46 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
OBTAINED
Date Written Consent Obta
ined
Aug/18/2020Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045786
Page 141 of 259
***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: 10061052 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-18-2020 14:06:30
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10061052Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 14:06:27
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020
14:07:02 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020
14:07:02 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045787
Page 142 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020
14:07:02 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
WHITEInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045788
Page 143 of 259
***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: 10061052 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
Sep-30-2020
04:25:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Per site
confirmation
Sep-29-2020
04:15:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Candid
ateAdded to DM
Ops tracker.
Kindly review the
Ops tracker and
take appropriate
action.
Sep-28-2020
11:46:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Deemed not
related to COVID
per investigator
Sep-28-2020
11:08:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Sonali shah
(pfe.shahs132)Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
31AUG2020. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045789
Page 144 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020
14:07:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Maddie Grote
(pfe.mgrote)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045790
Page 145 of 259
***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: 10061052 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-18-2020
14:07:39 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 14:07:39
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020
14:07:39 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045791
Page 146 of 259
***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: 10061052 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-18-2020 14:08:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:dyshidroctic
eczema
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 14:08:50
(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-18-2020
14:08:50 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
dyshidroctic eczemaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-18-2020
14:08:50 (UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2018Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045792
Page 147 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Canada)
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020
14:08:50 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-18-2020 14:09:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:DIABETES M
ELITUS TYPE
I
Start Date: UNK/UNK/198
9
Ongoing: YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045793
Page 148 of 259
***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: 10061052 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-18-2020 14:09:32
(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-18-2020
14:09:32 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
DIABETES MELITUS TYP
E IInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020
14:09:32 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/1989Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020
14:09:32 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-25-2020
11:02:01 (UTC-07:00)ACV0PFEINFP6000 Lindsey
BevanData Entry:
Line/MH N 3Transcription
Error
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045794
Page 149 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)(pfe.lbevan) umber:
Medical Hi
story Term
:ERECTILE D
YSFUNCTIO
N
Start Date: UNK/UNK/2
019
Ongoing: YES
Aug-21-2020
11:56:59 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term
:ERECTILE D
YSFUNCTIO
N
Start Date: UNK/UNK/2
019
Ongoing: YESChanged
Information
Aug-18-2020
14:10:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:3
Medic
al Hist
ory Te
rm:ERECTILE DYSF
UNCTION DUE T
O DIABETES ME
LITUS TYPE I
Start
Date:UNK/UNK/2019
Ongoi
ng:YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045795
Page 150 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 14:10:07
(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 ValueReason
Aug-26-2020
23:14:39
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query
2: Clo
sedResponse
satisfies query
Aug-25-2020
11:02:01
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dTranscription
Error
Aug-25-2020
11:02:01
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data
Entry
:
EREC
TILE
DYSF
UNC
TIONTranscription
Error
Aug-24-2020
07:09:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query
2: Op
enedDM: A trailing
space is
identified. To
avoid processing
errors, please
remove the
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045796
Page 151 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
identified
character by
deleting the entry
and re-entering
the data (without
using copy and
paste).
Aug-22-2020
21:24:29
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy has
been closed.
Aug-21-2020
11:56:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged
Information
Aug-21-2020
11:56:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data
Entry
:
EREC
TILE
DYSF
UNC
TIONChanged
Information
Aug-19-2020
05:28:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedMultiple
concepts in the
term ERECTILE
DYSFUNCTION
DUE TO
DIABETES
MELITUS
TYPE I. Split the
term into
ERECTILE
DYSFUNCTION
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045797
Page 152 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
and DIABETES
MELLITUS
TYPE I and
submit
separately. Thank
you.
Aug-18-2020
14:10:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Maddie Grote
(pfe.mgrote)Data
Entry
:
EREC
TILE
DYSF
UNC
TION
DUE
TO D
IABE
TES
MELI
TUS
TYPE
IInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020
14:10:07 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020
14:10:07 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045798
Page 153 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d
Date Location User Value Reason
Aug-18-2020 14:11:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:ERYTHROMYCI
N BASE INTOL
ERANCE
Start Dat
e:UNK/UNK/2002
Ongoing: YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045799
Page 154 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 14:11:00
(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-18-2020 14:11:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
ERYTHROMYCIN BASE I
NTOLERANCEInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 14:11:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 14:11:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-18-2020 14:11:20
(UTC-07:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 5Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045800
Page 155 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US &
Canada)mber:
Medical Hist
ory Term:RECURRIN
G COUGH
Start Date: UNK/UNK/2
014
Ongoing: YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045801
Page 156 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Aug-18-2020 14:11:20
(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-18-2020 14:11:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
RECURRING COUGHInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 14:11:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-18-2020 14:11:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-18-2020 14:11:59
(UTC-07:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH 6Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045802
Page 157 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US &
Canada)Number:
Medical H
istory Ter
m:CALCIFIC TEN
DINITIS RIGHT
HAND
Start Date
:Nov/3/2018
Ongoing: YES
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045803
Page 158 of 259
***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: 10061052 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-18-2020 14:11:59
(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-18-2020 14:11:59
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
CALCIFIC TENDINITIS RI
GHT HANDInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-18-2020 14:11:59
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Nov/3/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-18-2020 14:11:59
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045804
Page 159 of 259
***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: 10061052 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-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
241.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
70.5Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045805
Page 160 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-18-2020 14:12:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.1Initial Entry
7.a
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Record Identifi
er::1
Temperature: 98.4
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)ACV0PFEINFP6000 Maddie
GroteData Entry:
98.4Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045806
Page 161 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US &
Canada)(pfe.mgrote)
7.a Unit:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020
14:12:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045807
Page 162 of 259
***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: 10061052 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-18-2020
14:12:50 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020
14:12:50 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
53735Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045808
Page 163 of 259
***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: 10061052 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-19-2020 09:05:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 09:05:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
09:05:31 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020
09:05:20 (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-19-2020
09:05:20 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045809
Page 164 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug/18/2020
5.a
Date Location User Value Reason
Aug-19-2020 09:05:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2TPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 09:05:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2TPInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 09:05:38
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2TRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 09:05:38
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2TRInitial Entry
5.c
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045810
Page 165 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-19-2020 09:05:45
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2TSInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 09:05:45
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2TSInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 09:05:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BJ7LZWInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 09:05:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BJ7LZWInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020 09:06:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BJ7LZXInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045811
Page 166 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 09:06:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BJ7LZXInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045812
Page 167 of 259
***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: 10061052 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-18-2020 14:13:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 14:13:00
(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-19-2020
09:04:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto
Query
Aug-19-2020
09:04:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened There are more
than 1 barcode
present for
sample
collection. Please
review and
correct as
appropriate.
Aug-19-2020
09:04:06
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045813
Page 168 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)
Aug-18-2020
23:23:54
(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-18-2020
14:13:00
(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-18-2020
14:13:00
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
09:04:57 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2NLTranscription
Error
Aug-19-2020
09:04:06 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2TPInitial Entry
5.a Sample ID
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045814
Page 169 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-19-2020
09:04:57 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2NLTranscription
Error
Aug-19-2020
09:04:06 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2TPInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020
09:04:37 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID:Transcription
Error
Aug-19-2020
09:04:16 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
Sample ID: BHV2TRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020
09:04:37 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry: Transcription
Error
Aug-19-2020
09:04:16 (UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Heather
Littell
(pfe.hlittell)Data Entry:
BHV2TRInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045815
Page 170 of 259
***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: 10061052 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-18-2020
14:13:12 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 14:13:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 14:13:12
(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-18-2020
14:13:12 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
Aug/18/2020 14:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045816
Page 171 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020 14:13:12
(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-18-2020
14:13:12 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-18-2020 14:13:12
(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-18-2020 14:13:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-18-2020
14:13:12 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045817
Page 172 of 259
***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: 10061052 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-18-2020
14:13:19 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Maddie
Grote
(pfe.mgrote)Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045818
Page 173 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Sep-30-2020
04:25:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Per site
confirmation
Sep-29-2020
04:15:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Candid
ateAdded to DM
Ops tracker.
Kindly review the
Ops tracker and
take appropriate
action.
Sep-28-2020
11:46:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Deemed not
related to COVID
per investigator
Sep-28-2020
11:09:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Sonali shah
(pfe.shahs132)Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
22SEP2020. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045819
Page 174 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-08-2020
12:37:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
Sep/8/2020Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045820
Page 175 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
Record Identif
ier::1
Temperature: 98.8
Temperature
Unit:F
Temperature
Location::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
98.8Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045821
Page 176 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Unit:
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 12:37:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045822
Page 177 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Sep-08-2020 12:37:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 12:37:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
12:54:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
12:37:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-08-2020
12:37:58
(UTC-07:00)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045823
Page 178 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada) Sep/8/2020
5.a
Date Location User Value Reason
Sep-08-2020 12:54:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BCT8GZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 12:54:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
BCT8GZInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045824
Page 179 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
Sep/8/2020 11:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045825
Page 180 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 12:38:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Colby
Bostock
(pfe.cbostock)Data Entry:
YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045826
Page 181 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-09-2020 13:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Oct/9/2020Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045827
Page 182 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-09-2020 13:28:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 13:28:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 09:48:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-10-2020 03:15:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-09-2020 13:28:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045828
Page 183 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
entered. Please
review and
correct as
appropriate.
Oct-09-2020 13:28:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 09:48:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BCT8C9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 09:48:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BCT8C9Initial Entry
5.b
Date Location User Value Reason
Oct-13-2020 09:48:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7M6SInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045829
Page 184 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 09:48:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7M6SInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020 09:48:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7MCTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 09:48:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7MCTInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045830
Page 185 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-23-2020
12:20:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Josee Robillard
(pfe.robilj01)Query 2: Closed Response
satisfies query
Oct-23-2020
12:19:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Josee Robillard
(pfe.robilj01)Query 4: Closed Response
satisfies query
Oct-23-2020
10:52:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 4: Answered No assessements
performed at this
erroneous visit
Oct-23-2020
10:52:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: Answered No assessements
performed at this
erroneous visit
Oct-23-2020
06:49:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Deleted Duplicate query.
Oct-23-2020
06:47:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 4: Opened Erroneous Visit
is marked, but
date of visit is
entered. Please
check whether
other
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045831
Page 186 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
assessments are
performed at this
visit.
Oct-23-2020
06:46:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 2: Opened Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing. Please
review and
update as
appropriate.
Oct-22-2020
14:29:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate Erroneous Visit
is marked, but
date of visit is
entered. Please
check whether
other
assessments are
performed at this
visit.
Oct-22-2020
14:29:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto
Query
Oct-22-2020
14:29:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Sep/1/2020Transcription
Error
Oct-22-2020
14:19:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Date of Visit,
23/Oct/2020 is a
future date
relative to when
it was entered on
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045832
Page 187 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
22/Oct/2020.
Please correct.
Oct-22-2020
14:19:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing. Please
review and
update as
appropriate.
Oct-22-2020
14:19:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal Swab
Self and Nasal
Swab are
missing. Please
review and
update as
appropriate.
Oct-22-2020
14:19:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Oct/23/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Oct-22-2020 14:29:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045833
Page 188 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-22-2020 14:19:29
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045834
Page 189 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-23-2020
12:21:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Josee Robillard
(pfe.robilj01)Query 1: Closed closing as swab
was not done -
PD
Oct-23-2020
10:52:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: Answered No assessements
performed at this
erroneous visit
Oct-23-2020
06:55:00
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Opened Date of Visit is
completed but
Date of
Collection in
both Nasal Swab
Self and Nasal
Swab are
missing. Please
review and
update as
appropriate.
Oct-22-2020
14:30:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-22-2020
14:29:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045835
Page 190 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptoms form
is missing. Please
review and
update as
appropriate.
Oct-22-2020
14:29:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal Swab
Self and Nasal
Swab are
missing. Please
review and
update as
appropriate.
Oct-22-2020
14:29:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Sep/23/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-22-2020 14:29:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045836
Page 191 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sep/23/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sep/18/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
Date of Last Symptom Res
olved:
Sep/18/2020Initial Entry
4.a
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045837
Page 192 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045838
Page 193 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.b Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sympt
oms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045839
Page 194 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.c Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045840
Page 195 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.d Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045841
Page 196 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.e Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Presen
t:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045842
Page 197 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.f Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045843
Page 198 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.g Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: DIARRH
EA
Symptom Prese
nt:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045844
Page 199 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.h Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045845
Page 200 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.i Symptoms:
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-22-2020 14:30:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045846
Page 201 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045847
Page 202 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-22-2020 14:30:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045848
Page 203 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-22-2020 14:31:07
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 14:31:07
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 14:31:07
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-22-2020 14:31:07
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Protocol DeviationInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045849
Page 204 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-22-2020 14:31:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 14:31:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 14:31:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-22-2020 14:31:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Telehealth visitInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045850
Page 205 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practit
ioner:EMERGE
NCY ROO
MInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045851
Page 206 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Occurrence of
Visits or Conta
cts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Pract
itioner:PRIMARY
CARE PHY
SICIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045852
Page 207 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045853
Page 208 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Prac
titioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045854
Page 209 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
TELEPHONE CONSULTAT
IONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045855
Page 210 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-22-2020 14:31:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045856
Page 211 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-22-2020 14:31:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILL
NESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-22-2020 14:31:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020 14:31:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
1Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045857
Page 212 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 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
Oct-27-2020
17:54:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
Oct/27/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-27-2020
17:54:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
COVID_B1Initial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045858
Page 213 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 10061052 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
Oct-27-2020 17:54:41
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 17:54:41
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
16:21:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-28-2020
04:49:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-27-2020
17:54:41
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045859
Page 214 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)barcodes are
entered. Please
review and
correct as
appropriate.
Oct-27-2020
17:54:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 16:21:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BH244GInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 16:21:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BH244GInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 16:21:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BSJPKTInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045860
Page 215 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 16:21:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BSJPKTInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 16:21:39
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7MGMInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 16:21:39
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7MGMInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045861
Page 216 of 259
***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: 10061052 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
Oct-09-2020 13:28:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 13:28:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 13:28:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045862
Page 217 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-26-2020 10:24:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Deleted Captured on
COVID
Illness visit
Sep-24-2020 12:20:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045863
Page 218 of 259
***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: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-19-2021 10:31:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Form Created
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045864
Page 219 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 12:20:51
(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-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020
12:08:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Vrunda
Parikh
(pfe.parikv06)Query 2: Closed Response satisfies
query
Oct-26-2020
10:24:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Captured on
COVID Illness
visit
Oct-26-2020
00:04:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Sathenapalli
Suguna
Srujan
(pfe.srujas)Query 2: Opened CLINQUERY:
Potential
COVID-19 listed
symptoms
VOMITTING is
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045865
Page 220 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
already
documented under
the COVID
Illness SOD CRF.
PP Section 8.37,
events consistent
with the clinical
endpoint
definition are not
to then also be
recorded as AEs.
Update AE CRF
as appropriate
Oct-25-2020
10:41:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Vrunda
Parikh
(pfe.parikv06)Query 2: Candidate CLINQUERY:
Potential
COVID-19 listed
symptoms
VOMITTING is
already
documented under
the COVID
Illness SOD CRF.
PP Section 8.37,
events consistent
with the clinical
endpoint
definition are not
to then also be
recorded as AEs.
Update AE CRF
as appropriate.
Sep-30-2020
18:07:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Closed Response satisfies
query
Sep-30-2020
10:12:51ACV0PFEINFP6000 Lindsey
BevanQuery 1: Answered Original value is
correct
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045866
Page 221 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-07:00)
Mountain Time (US
& Canada)(pfe.lbevan)
Sep-29-2020
04:22:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Opened In error actioned
this query
Sep-29-2020
04:14:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Candid
ateAdded to DM Ops
tracker. Kindly
review the Ops
tracker and take
appropriate
action.
Sep-28-2020
11:45:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Deemed not
related to COVID
per investigator
Sep-26-2020
18:44:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Opened ClinQuery: Since
Vomiting is one of
CDC-defined
symptoms of
COVID-19 (see
protocol section
8.1), please
consider whether
this symptom
could have been
due to COVID-19
and should have
triggered a
potential illness
visit, please
complete COVID
illness CRF.
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045867
Page 222 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-24-2020
12:20:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
VOMITTINGInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sep/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020 12:20:51
(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).
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045868
Page 223 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Sep-24-2020 12:20:51
(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-24-2020 12:20:51
(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-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to
:
OTHER
If Other, specify:
FOOD DIDN'T SIT W
ELLInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045869
Page 224 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 12:20:51
(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-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECOVERED/RESOLVED
WITH SEQUELAEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 12:20:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045870
Page 225 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021 10:31:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021 10:31:49
(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
Mar-10-2021
19:23:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Mar-09-2021
11:41:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 2: Answered Submitted on
3.5.21
Mar-08-2021
15:31:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response
satisfies query
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045871
Page 226 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-08-2021
15:31:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed Response
satisfies query
Mar-08-2021
15:28:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opene
dClinical - please
submit the
corrected event
term 'Exposure
during Partner
Pregnancy' as a
PG safety update
ASAP
Mar-08-2021
09:49:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 4: Answered EDP with this
information
provided on
2.19.21
Mar-08-2021
09:48:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 3: Answered Report to safety
database lists Vax
1 as 8.18.20 and
Vax 2 as 9.8.20 as
reported on
3/1/21 and
3/4/21.
Mar-08-2021
09:45:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 2: Answered You're welcome
Mar-05-2021
21:52:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opene
dClinical - Thank
you; please
submit the
updated event
term to the PG
Safety report by
FAX
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045872
Page 227 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-05-2021
21:51:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissued:Opene
dClinical - PG
safety report has
VAX 1/2 as
19Aug and
09Sep, 2020;
however, Inform
VAX logs have
18Aug and
08Sep, 2020.
Please review,
harmonize
reporting, and
update in the
appropriate
location
Mar-05-2021
21:46:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Reissued:Opene
dClinical - please
submit a PG
safety update,
stating outcome
of subject's
female partner's 1
prior pregnancy,
and complete
EDP
supplemental
form for Mother
info & social
history
Mar-05-2021
16:00:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed
Information
Mar-05-2021
16:00:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed
Information
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045873
Page 228 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061052 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-05-2021
16:00:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Mar-05-2021
16:00:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Exposure During Partner
PregnancyChanged
Information
Mar-02-2021
20:44:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened Clinical - please
submit a PG
safety update,
stating outcome
of subject's
female partner's 1
prior pregnancy,
and complete
EDP
supplemental
form for Mother
info & social
history
Mar-02-2021
20:04:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical - please
submit a PG
Safety update to
report the VAX1
date (18Aug20),
in Med Hx
section of SAE,
along with
subject's medical
history conditions
Mar-02-2021
19:57:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical - As the
event is for the
Non-subject
(subject's
partner), the
pregnancy term
090177e196ae3d41\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-00458
…[truncated]