Document text
Page 1 of 288
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046381
Page 2 of 288
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 10061176 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
Oct/13/2020
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046382
Page 3 of 288
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061176]
2.Birth Date: /2004
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0046383
Page 4 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046384
Page 5 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046385
Page 6 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046386
Page 7 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10061176 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:[Migraines]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Asthma]
Start Date: UNK/UNK/2011
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046387
Page 8 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046388
Page 9 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [140.3]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046389
Page 10 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046390
Page 11 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [105602]
3.Randomization Group: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046391
Page 12 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [BH244F]
5.bSample ID [BSJPKS]
5.cSample ID [BJ7MGL]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046392
Page 13 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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:
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 [BH249Z]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046393
Page 14 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
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: 10061176 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?YES
Date of First Delay:
Oct/13/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/27/2020 17:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046394
Page 15 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046395
Page 16 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046396
Page 17 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7] Comments
Unit: F Comments
Temperature Location: ORAL CAVITY Comments
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046397
Page 18 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS Comments
2.Lab Sub-Panel: PREGNANCY Comments
3.Collection Date: Nov/19/2020 Comments
4.Laboratory Name and Address
(Derived)[STUDY SITE] Comments
5.Specimen Type: URINE Comments
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE Comments
Not Done: Comments
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046398
Page 19 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? YES
Date of Collection:
Nov/19/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BH24BB]
5.bSample ID [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046399
Page 20 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO Comments
2.Treatment Name [BLINDED THERAPY] Comments
3.Formulation: INJECTION Comments
4.Dose Date Time: Nov/19/2020 17:41 Comments
5.Anatomical Location: DELTOID MUSCLE Comments
6.Body Side: LEFT Comments
7.Route: INTRAMUSCULAR Comments
8.Actual Dose: [ ] Comments
9.Unit: Comments
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES Comments
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046400
Page 21 of 288
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 Dec/29/2020
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046401
Page 22 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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:
Dec/29/2020
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 [BRL0TR]
5.bSample ID [BJ7MP8]
5.cSample ID [BJ7ML8]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046402
Page 23 of 288
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046403
Page 24 of 288
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046404
Page 25 of 288
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046405
Page 26 of 288
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046406
Page 27 of 288
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046407
Page 28 of 288
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046408
Page 29 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 Nov/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046409
Page 30 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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: Nov/11/2020
2.Date of First Symptom Started: Nov/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/20/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046410
FDA-CBER-2021-5683-0046411
Page 32 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046412
Page 33 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV49749]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046413
Page 34 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046414
Page 35 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046415
FDA-CBER-2021-5683-0046416
Page 37 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: HOSPITALIZATION DETAILS
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: 10061176 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
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/8/2021
4.Ongoing? NO
Discharge Date:
Feb/10/2021
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046417
FDA-CBER-2021-5683-0046418
Page 39 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046419
Page 40 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046420
FDA-CBER-2021-5683-0046421
Page 42 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046422
Page 43 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046423
Page 44 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046424
Page 45 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046425
Page 46 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046426
FDA-CBER-2021-5683-0046427
Page 48 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: VITAL SIGNS - COVID
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/8/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [105]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [133]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046428
FDA-CBER-2021-5683-0046429
Page 50 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/8/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [91.0]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046430
FDA-CBER-2021-5683-0046431
Page 52 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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): [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046432
Page 53 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046433
Page 54 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046434
FDA-CBER-2021-5683-0046435
Page 56 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046436
Page 57 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046437
Page 58 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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: Feb/10/2021
2.Date of First Symptom Started: Feb/3/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046438
Page 59 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/8/2021
SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046439
Page 60 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/8/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [clia certified]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046440
Page 61 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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? YES
Date of Collection:
Feb/10/2021
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 [CV46529]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046441
Page 62 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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:[self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046442
Page 63 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046443
FDA-CBER-2021-5683-0046444
Page 65 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: HOSPITALIZATION DETAILS
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/8/2021
4.Ongoing? NO
Discharge Date:
Feb/10/2021
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046445
FDA-CBER-2021-5683-0046446
Page 67 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046447
Page 68 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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?YES
Respiratory Illness Diagnosis:
[strep throat]
Date of Diagnosis:
Feb/8/2021
3.Toxicity Grade: 3
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046448
FDA-CBER-2021-5683-0046449
Page 70 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046450
Page 71 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046451
Page 72 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046452
Page 73 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046453
Page 74 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046454
FDA-CBER-2021-5683-0046455
Page 76 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046456
FDA-CBER-2021-5683-0046457
Page 78 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 % [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046458
FDA-CBER-2021-5683-0046459
Page 80 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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): [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046460
Page 81 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046461
Page 82 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046462
FDA-CBER-2021-5683-0046463
Page 84 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/10/2021Form: 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: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046464
Page 85 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10061176 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 Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046465
Page 86 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10061176 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:
Dec/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BCSY13]
5.bSample ID [BS8WJ3]
5.cSample ID [BS8WJY]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046466
Page 87 of 288
***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: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046467
Page 88 of 288
***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: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046468
Page 89 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Acute Asthma Exacerb
ation Feb/3/2021 UNK:U
NK NO
End Date Time:
Feb/10/2021 UNK:UNK
Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046469
Page 90 of 288
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Asthma Exacerbation]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[strep pharyngitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046470
Page 91 of 288
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021148838]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046471
Page 92 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046472
Page 93 of 288
***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: 10061176 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[ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046473
Page 94 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart Dat
eForm Instance
1.1 VACCINATIONS NO Influenza Vaccin
e Oct/10/20
20 Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046474
Page 95 of 288
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 10061176 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/10/2020
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046475
Page 96 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. DELETED 1 CORTICOSTER
OIDS NO Prednisone 30 Repeating
Pages
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046476
Page 97 of 288
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
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).[Prednisone ]
5.Dose: [30]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: ORAL
9.Start Date: Feb/6/2021
10.Ongoing? NO
End Date:
Feb/14/2021
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046477
FDA-CBER-2021-5683-0046478
Page 99 of 288
***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: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046479
FDA-CBER-2021-5683-0046480
Page 101 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046481
Page 102 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046482
Page 103 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046483
Page 104 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046484
Page 105 of 288
***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: 10061176 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:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046485
Page 106 of 288
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046486
Page 107 of 288
***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: 10061176 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?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046487
Page 108 of 288
***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: 10061176 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: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046488
Page 109 of 288
***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: 10061176 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: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046489
Page 110 of 288
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046490
Page 111 of 288
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046491
Page 112 of 288
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046492
Page 113 of 288
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046493
Page 114 of 288
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 :Dec/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046494
Page 115 of 288
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 10061176 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 Jan/28/2021
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046495
Page 116 of 288
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046496
Page 117 of 288
***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: 10061176 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: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046497
Page 118 of 288
***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: 10061176 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/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046498
Page 119 of 288
***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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046499
Page 120 of 288
***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: 10061176 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: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046500
Page 121 of 288
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046501
Page 122 of 288
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046502
Page 123 of 288
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046503
Page 124 of 288
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046504
Page 125 of 288
***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: 10061176 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 Dec/29/2020
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046505
Page 126 of 288
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Casebook Signature Form
1.Casebook Signature
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046506
Page 127 of 288
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10061176 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046507
Page 128 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-13-2020 18:01:50 (UTC-07:00) Mountain Time
(US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046508
Page 129 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-28-2020 16:29:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046509
Page 130 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-23-2020 15:06:23 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)
FormNov-06-2020 12:27:59 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
FormNov-04-2020 09:03:25 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046510
Page 131 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-23-2020 15:06:23 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
1Nov-06-2020 12:27:59 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
1Nov-04-2020 09:03:25 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046511
Page 132 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aNov-23-2020 15:06:23 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2.aNov-06-2020 12:27:59 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2.aNov-04-2020 09:03:25 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046512
Page 133 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aNov-23-2020 15:06:23 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2.aNov-06-2020 12:27:59 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2.aNov-04-2020 09:03:25 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046513
Page 134 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aNov-23-2020 15:06:23 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2.aNov-06-2020 12:27:59 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2.aNov-04-2020 09:03:25 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046514
Page 135 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-23-2020 15:13:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)
FormNov-06-2020 12:28:11 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
FormNov-04-2020 09:03:45 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046515
Page 136 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
1Nov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
1Nov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046516
Page 137 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2Nov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2Nov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046517
Page 138 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
3Nov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
3Nov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046518
Page 139 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
4Nov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
4Nov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046519
Page 140 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Nov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
5Nov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
5Nov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046520
Page 141 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aNov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
6.aNov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
6.aNov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046521
Page 142 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aNov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
6.aNov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
6.aNov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046522
Page 143 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aNov-23-2020 15:13:11 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
6.aNov-06-2020 12:28:11 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
6.aNov-04-2020 09:03:45 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046523
Page 144 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-23-2020 15:13:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)
FormNov-03-2020 11:50:35 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046524
Page 145 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-23-2020 15:13:49 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
1Nov-03-2020 11:50:35 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046525
Page 146 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-23-2020 15:13:49 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2Nov-03-2020 11:50:35 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046526
Page 147 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-23-2020 15:13:49 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
3Nov-03-2020 11:50:35 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046527
Page 148 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-23-2020 15:13:49 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
4Nov-03-2020 11:50:35 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046528
Page 149 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-23-2020 15:15:25 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)
FormNov-06-2020 12:28:26 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
FormNov-04-2020 09:04:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046529
Page 150 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
1Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
1Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046530
Page 151 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
2Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046531
Page 152 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
3Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
3Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046532
Page 153 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
4Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
4Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046533
Page 154 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
5Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
5Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046534
Page 155 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
6Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
6Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046535
Page 156 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
7Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
7Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046536
Page 157 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
8Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
8Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046537
Page 158 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
9Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
9Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046538
Page 159 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
10Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
10Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
10Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046539
Page 160 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
11Nov-23-2020 15:15:25 (UTC-07:00) Mountain Time
(US & Canada)Bradley Young
(pfe.byoung)
11Nov-06-2020 12:28:26 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
11Nov-04-2020 09:04:00 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046540
Page 161 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-11-2020 16:10:49 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046541
Page 162 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046542
Page 163 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046543
Page 164 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046544
Page 165 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046545
Page 166 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046546
Page 167 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046547
Page 168 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046548
Page 169 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046549
Page 170 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: 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: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Nov-11-2020 16:10:49 (UTC-07:00) Mountain Time
(US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046550
Page 171 of 288
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 10061176 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046551
Page 172 of 288
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-13-2020 18:01:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-13-2020 18:01:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046552
Page 173 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-29-2020 05:28:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query 1: Closed Response satisfies
query
Oct-28-2020 16:33:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Subject met delay
criteria
Oct-28-2020 16:27:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Oct-13-2020 18:01:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/13/2020Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046553
Page 174 of 288
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-13-2020 18:00:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10061176Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-13-2020 18:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/2004Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-13-2020 18:01:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-13-2020 18:01:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-13-2020 18:01:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
WHITEInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0046554
Page 175 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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-29-2020
19:46:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: Clo
sedAuto closed by
Validation Check:
VC_SV001_02
Oct-29-2020
12:42:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: Ans
weredDate for V2 entered
in error
Oct-28-2020
23:31:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: Ope
nedDMW5210935;The
Date of Visit at Visit
V1_DAY1_VAX1_L
is the same as the
other Date of Visit at
Visit V2_VAX2_L.
Please review for
duplication and
update as
appropriate.
Oct-28-2020
16:59:52
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Christopher Lewis
(pfe.lewisc45)Query 1: Clo
sedResponse satisfies
query
Oct-28-2020
16:27:49
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged Information
Oct-28-2020
16:27:49
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Oct/27/2020Changed Information
Oct-28-2020
15:17:17
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Christopher Lewis
(pfe.lewisc45)Query 1: Ope
nedPer CRF guidelines if
temporary delay
occurs DOV should
be updated to reflect
the date of
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046555
Page 176 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
vaccination. This will
cure all queries on
these pages.
Oct-13-2020
18:01:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily Wilcox
(pfe.ewilcox)Data Entry:
Oct/13/2020Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046556
Page 177 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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-13-2020 18:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 18:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 18:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046557
Page 178 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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-27-2020 18:13:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Migraines
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:13:05
(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
Oct-27-2020 18:13:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
MigrainesInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-27-2020 18:13:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-27-2020 18:13:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-27-2020 18:13:31 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046558
Page 179 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00) Mountain
Time (US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:Depression
Start Date: UNK/UNK/20
18
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:13:31
(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
Oct-27-2020 18:13:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
DepressionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-27-2020 18:13:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-27-2020 18:13:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-27-2020 18:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Anxiety
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046559
Page 180 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 18:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
AnxietyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-27-2020 18:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-27-2020 18:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-27-2020 18:14:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Asthma
Start Date: UNK/UNK/20
11
Ongoing: YESInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046560
Page 181 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:14:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 18:14:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
AsthmaInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-27-2020 18:14:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
UNK/UNK/2011Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-27-2020 18:14:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-27-2020 18:15:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Seasonal Allergi
es
Start Date: UNK/UNK/201
1
Ongoing: YESInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046561
Page 182 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:15:03
(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
Oct-27-2020 18:15:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Seasonal AllergiesInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-27-2020 18:15:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-27-2020 18:15:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046562
Page 183 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-27-2020 18:11:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046563
Page 184 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
140.3Initial Entry
3. Unit:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.9Initial Entry
7.a
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046564
Page 185 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-27-2020 18:11:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046565
Page 186 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Oct/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046566
Page 187 of 288
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-27-2020 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046567
Page 188 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-29-2020 05:26:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query 1: Closed DOV updated
Oct-28-2020 15:53:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: Answered Randomization date
correct. DOV to be
updated.
Oct-27-2020 18:11:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Randomization Date
27/Oct/2020 is before
or more than 1 day
after corresponding
Date of Visit 13/Oct
/2020. Please review
and update as
appropriate.
Oct-27-2020 18:11:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe.mgrimmett)Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-27-2020 18:11:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
105602Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046568
Page 189 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 18:07:40
(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 18:07:40
(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
19:34:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_04
Oct-28-2020
15:53:46
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: An
sweredDate of collection
correct. DOV to be
updated.
Oct-28-2020
01:38:46
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: Op
enedDMW5202595;Date
of Collection is earlier
or more than 1 day
after Date of Visit.
Please clarify or
correct.
Oct-27-2020
18:08:04
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Del
etedClose Auto Query
Oct-27-2020
18:07:40
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Ca
ndidate'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046569
Page 190 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) correct as appropriate.
Oct-27-2020
18:07:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Megan Grimmett
(pfe mgrimmett)Data Entry:
YES
Date of Col
lection:
Oct/27/20
20Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 18:08:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Sample ID: BH244FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 18:08:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
BH244FInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 18:08:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Sample ID: BSJPKSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 18:08:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
BSJPKSInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 18:08:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Sample ID: BJ7MGLInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046570
Page 191 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 18:08:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
BJ7MGLInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046571
Page 192 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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 18:07:48
(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 18:07:48
(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-29-2020 05:27:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe ks66)Query 2: Closed Response satisfies
query
Oct-28-2020 15:53:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: Answered DOV to be updated.
Oct-27-2020 18:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 18:09:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of Collection
27/Oct/2020 is more
than 1 day after Date
of Visit 13/Oct/2020.
Please review and
update as appropriate,
else clarify.
Oct-27-2020 18:09:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YES
Date of Collection:
Oct/27/2020Transcription Error
Oct-27-2020 18:07:48
(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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046572
Page 193 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
correct as appropriate.
Oct-27-2020 18:07:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Oct-27-2020 18:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Sample ID: BH249ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 18:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
BH249ZInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046573
Page 194 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-13-2020 18:02:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES
Date of First Delay:
Oct/13/2020
Reason(s) for Temporary Delay of V
accination
RECENT NON-STUDY VACCIN
ATIONInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-29-2020 05:47:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe ks66)Query 1: Closed Response satisfies
query
Oct-28-2020 15:54:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: Answered DOV to be updated.
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date is before or
more than 1 day after
Date of Visit
13/Oct/2020 of the
corresponding Visit.
Please review and
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046574
Page 195 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
update as appropriate.
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
Oct/27/2020 17:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-27-2020 18:16:04
(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
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-27-2020 18:16:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
YESInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046575
Page 196 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Oct-27-2020 18:12:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Megan
Grimmett
(pfe mgrimmett)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046576
Page 197 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020
16:17:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Clo
sedClose Auto Query
Nov-24-2020
02:00:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Jayesh Yeole
(pfe.yeolej)Query 3: Op
enedDM: Erroneous Visit
is marked, but date of
visit is entered. Please
either, untick the
erroneous visit button
if visit occurred, or
clear the data from
rest of forms if
entered in error and
update accordingly or
else clarify.
Nov-23-2020
15:05:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Ca
ndidateErroneous Visit is
marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this
visit.
Nov-23-2020
15:05:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Bradley Young
(pfe.byoung)Data Entry:
Nov/19/2020Transcription Error
Nov-07-2020
02:16:52
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Sandip Namdeorao
Suryawanshi
(pfe.suryas18)Query 2: Clo
sedResponse satisfies
query
Nov-06-2020
12:29:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: An
sweredForm level comment
changed to Not
Applicable per DM
request as it was
previously requested
to be NOT DONE.
Nov-05-2020 ACV0PFEINFP6000 Usha Ogirala Query 2: Rei DM2: Please review
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046577
Page 198 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
02:45:08
(UTC-07:00)
Mountain Time
(US & Canada)(pfe.ogirau) ssued:Opene
dand add form level
comment as Not
Applicable on the
forms of this visit or
else clarify. Thank
you.
Nov-04-2020
09:04:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: An
sweredChanged data per
query
Nov-04-2020
02:44:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Usha Ogirala
(pfe.ogirau)Query 2: Rei
ssued:Opene
dDM1: As previous
response confirms
this visit is erroneous
visit. Please add form
level comment of
NOT DONE in all the
forms of this visit.
Thank you.
Nov-03-2020
11:51:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 2: An
sweredUnable to erase date
entered in error for
erroneous visit
Nov-02-2020
06:21:00
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Vikas Joshi
(pfe.joshiv22)Query 2: Op
enedDM: Erroneous Visit
is marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this
visit. If not, consider
to add 'Not
Applicable' form
level comment to rest
of the forms.
Oct-29-2020
23:33:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Gajanan Deshmukh
(pfe.deshmg08)Query 1: Clo
sedResponse satisfies
query
Oct-29-2020
12:42:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query 1: An
sweredDate for V2 entered
in error
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046578
Page 199 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-29-2020
12:42:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ca
ndidateErroneous Visit is
marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this
visit.
Oct-28-2020
23:31:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW5210936;The
Date of Visit at Visit
V2_VAX2_L is the
same as the other
Date of Visit at Visit
V1_DAY1_VAX1_L.
Please review for
duplication and
update as appropriate.
Oct-28-2020
16:28:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Data Entry:
Oct/27/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-24-2020 16:17:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Transcription Error
Oct-29-2020 12:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046579
Page 200 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-23-2020 15:06:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Nov/19/2020Initial Entry
Nov-23-2020 15:06:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 15:06:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Record Identifier:: Not Done
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
Nov-23-2020 15:06:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Record Identifier:: Not Done
Temperature:
Temperature Unit:
Temperature Location::Initial Entry
Nov-06-2020 12:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Record Identifier:: Not Done
Temperature: Not Applicab
le
Temperature Unit: Not Applicab
le
Temperature Locatio
n::Not Applicab
leInitial Entry
Nov-04-2020 09:03:25
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
Record Identifier:: Not DoneInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046580
Page 201 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan) Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not Done
2.a Record Identifier:
Date Location User Value Reason
Nov-04-2020 09:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Nov-23-2020 15:06:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
97.7Initial Entry
Nov-23-2020 15:06:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Nov-23-2020 15:06:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
FInitial Entry
Nov-23-2020 15:06:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046581
Page 202 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-23-2020 15:06:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
ORAL CAVITYInitial Entry
Nov-23-2020 15:06:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046582
Page 203 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Nov/19/2020Initial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046583
Page 204 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046584
Page 205 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) Sponsor-Defined Identif
ier:113
Test:: Not Done
Result:: NEGATIV
E
Not Done::
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Sponsor-Defined Identifie
r:
Test:: Not Don
e
Result::
Not Done::Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Done
Result:: Not Applica
ble
Not Done:: Not Applica
bleInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sponsor-Defined Identifie
r:Not Don
e
Test:: Not Don
e
Result:: Not Don
e
Not Done:: Not Don
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046585
Page 206 of 288
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Nov-23-2020 15:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
NEGATIVEInitial Entry
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-23-2020 15:13:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:03:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046586
Page 207 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Nov-23-2020 15:14:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Nov-23-2020 15:13:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Nov-03-2020 11:50:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-28-2020 16:29:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-28-2020 16:28:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 15:14:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
Nov-23-2020 15:13:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Nov-03-2020 11:50:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-28-2020 16:29:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-28-2020 16:28:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046587
Page 208 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-23-2020 15:15:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Deleted Close Auto Query
Nov-23-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-23-2020 15:14:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Nov-23-2020 15:14:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-23-2020 15:14:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
Nov-23-2020 15:13:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-04-2020 09:54:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Christopher
Lewis
(pfe.lewisc45)Query 3: Closed Response satisfies
query
Nov-03-2020 11:50:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 3: Answered Changed data per
query
Nov-03-2020 11:50:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-02-2020 14:13:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Christopher
Lewis
(pfe.lewisc45)Query 3: Opened Please enter a form
level comment
indicating N/A until
this visit occurs.
Oct-28-2020 16:29:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046588
Page 209 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-28-2020 16:29:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Transcription Error
Oct-28-2020 16:29:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-28-2020 16:28:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 16:28:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-28-2020 16:28:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-23-2020 15:13:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-03-2020 11:50:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Nov-23-2020 15:15:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Sample ID: BH24BBInitial Entry
Oct-28-2020 16:29:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID:Transcription Error
Oct-28-2020 16:28:38
(UTC-07:00) MountainACV0PFEINFP6000 Lindsey
BevanData Entry:
Sample ID: BH249ZInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046589
Page 210 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan)
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 15:15:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
BH24BBInitial Entry
Oct-28-2020 16:29:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry: Transcription Error
Oct-28-2020 16:28:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BH249ZInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Sample ID:Transcription Error
Nov-23-2020 15:14:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Sample ID: BH24BBInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-23-2020 15:15:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Transcription Error
Nov-23-2020 15:14:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
BH24BBInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046590
Page 211 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
NOInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046591
Page 212 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
Nov/19/2020 17:41Initial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) MountainACV0PFEINFP6000 Bradley
YoungData Entry:
LEFTInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046592
Page 213 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.byoung)
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046593
Page 214 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-23-2020 15:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry:
YESInitial Entry
Nov-23-2020 15:15:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Bradley
Young
(pfe.byoung)Data Entry: Initial Entry
Nov-06-2020 12:28:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 09:04:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046594
Page 215 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-19-2021
00:29:53
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query
2: Clo
sedPer site confirmation_Updated
PD tracker
Jan-18-2021
17:34:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Colby Bostock
(pfe.cbostock)Query
2: Ans
wereddate correct as entered, will
report this pd
Jan-17-2021
23:25:28
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
2: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 5 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. "[naikp09
SDQ=91629]"
Dec-30-2020
23:55:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Amol Deshmukh
(pfe.deshma24)Query
1: Clo
sedResponse satisfies query
Dec-30-2020
10:27:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Lindsey Bevan
(pfe.lbevan)Query
1: Ans
weredChanged data per query
Dec-30-2020
04:27:57
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query
1: Op
enedDM: The treatment period is
defined as 1st vaccination visit
through the 1-month post
vaccination visit after the 2nd
vaccination. Please complete
treatment disposition CRF and
update date of EOT to match
date of visit at visit 3.
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046595
Page 216 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-29-2020
12:44:20
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Heather Littell
(pfe.hlittell)Data
Entry
:
Dec/2
9/202
0Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046596
Page 217 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Dec-29-2020 12:44:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-29-2020 12:44:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020 10:27:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-30-2020 00:00:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-29-2020 12:44:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-29-2020 12:44:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather Littell
(pfe hlittell)Data Entry:
YES
Date of Collection:
Dec/29/2020Initial Entry
5.a
Date Location User Value Reason
Dec-30-2020 10:27:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BRL0TRInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046597
Page 218 of 288
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Dec-30-2020 10:27:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BRL0TRInitial Entry
5.b
Date Location User Value Reason
Dec-30-2020 10:27:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7MP8Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-30-2020 10:27:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7MP8Initial Entry
5.c
Date Location User Value Reason
Dec-30-2020 10:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7ML8Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-30-2020 10:27:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7ML8Initial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046598
Page 219 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Feb-25-2021 03:26:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe ks66)Query 3: Closed Response satisfies
query
Feb-24-2021 11:18:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Query 3: Answered Changed data per query
Feb-22-2021 06:59:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 3: Opened DM: Kindly consider to
update missing
HOSPITALIZATION
DETAILS form or else
clarify. Thank you.
Nov-11-2020 16:11:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-11-2020 16:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the Signs
and Symptoms form is
missing. Please review
and update as
appropriate.
Nov-11-2020 16:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-11-2020 16:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Nov/11/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046599
Page 220 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-11-2020 16:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046600
Page 221 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Nov/11/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Nov/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-16-2020 11:50:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
Date of Last Symptom Resolved:
Nov/20/2020New Information
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(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
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046601
Page 222 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046602
Page 223 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.c Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(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
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046603
Page 224 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.e Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED MUSCLE PA
INInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(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
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom
Present:NOInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046604
Page 225 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.g Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(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
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046605
Page 226 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.i Symptoms:
Date Location User Value Reason
Nov-11-2020 16:10:39
(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
Nov-11-2020 16:10:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046606
Page 227 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
7. Test Result:
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046607
Page 228 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061176 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(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
Nov-11-2020 16:10:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d3f\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046608
Page 229 of 288
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Comp
…[truncated]