125742 S1 M5 CRF c4591001 1009 10091135

Document text

Page 1 of 272
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134342
Page 2 of 272
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134343
Page 3 of 272
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10091135]
2.Birth Date: 1957
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:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134344
Page 4 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134345
Page 5 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134346
Page 6 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134347
Page 7 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ENVIRONMENTAL ALLERGIES]
Start Date: UNK/UNK/1958
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MILD ASTHMA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS (GENERALIZED)]
Start Date: Jun/UNK/2019
Ongoing: YES
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134348
Page 8 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: Jun/UNK/2011
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: Jun/UNK/2011
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANXIETY]
Start Date: Jun/UNK/2011
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MTHFR GENE MUTATION]
Start Date: /1957
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ASPIRIN INTOLERANCE]
Start Date: UNK/UNK/1986
Ongoing: YES
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134349
Page 9 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GLUTEN INTOLERANCE]
Start Date: UNK/UNK/2003
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LACTOSE INTOLERANCE]
Start Date: UNK/UNK/1970
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MORPHINE INTOLERANCE]
Start Date: UNK/UNK/1986
Ongoing: YES
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134350
Page 10 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [243.2]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [41.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134351
Page 11 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134352
Page 12 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [244646]
3.Randomization Group: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134353
Page 13 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9GKG]
5.bSample ID [BP9GKH]
5.cSample ID [BP9GKJ]
5.dSample ID [BPR980]
5.eSample ID [BPR981]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134354
Page 14 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9G29]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134355
Page 15 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 13:44
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
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134356
Page 16 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134357
Page 17 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134358
Page 18 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134359
Page 19 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134360
Page 20 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BP9G84]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134361
Page 21 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 16:22
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
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134362
Page 22 of 272
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134363
Page 23 of 272
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9FNH]
5.bSample ID [BKYCYM]
5.cSample ID [BKYCVC]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134364
Page 24 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134365
Page 25 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134366
Page 26 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134367
Page 27 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134368
Page 28 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134369
Page 29 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134370
Page 30 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134371
Page 31 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134372
Page 32 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4 hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134373
Page 33 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Collec
tionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice Typ
eForm Instanc
e
 1.Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134374
Page 34 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134375
Page 35 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134376
Page 36 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134377
Page 37 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:Not Applicable Comments
Health Care Utilization Other
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134378
Page 38 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.Other Type of Practitioner
Specify:Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?Not Applicable Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134379
Page 39 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134380
Page 40 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134381
Page 41 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134382
Page 42 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134383
Page 43 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Page 44 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134385
Page 45 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134386
Page 46 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134387
Page 47 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134388
Page 48 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134389
Page 49 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134390
Page 50 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134391
Page 51 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Page 52 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134393
Page 53 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134394
Page 54 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134395
Page 55 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134396
Page 56 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134397
Page 57 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134398
Page 58 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
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FDA-CBER-2021-5683-0134399
Page 59 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134400
Page 60 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134401
Page 61 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134402
Page 62 of 272
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134403
Page 63 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134404
Page 64 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134405
Page 65 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134406
Page 66 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  right breast lump  Sep/2/2020 UN
K:UNK YES  Repeating
Pages
 2.ADVERSE E
VENT 2  Right Breast Ductal Carci
noma In Situ Sep/2/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134407
Page 67 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[right breast lump]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[cancer]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134408
Page 68 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134409
Page 69 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right Breast Ductal Carcinoma In Situ]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134410
Page 70 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
[spontaneous onset]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020411592]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134411
Page 71 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134412
Page 72 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134413
Page 73 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134414
Page 74 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134415
Page 75 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134416
Page 76 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134417
Page 77 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134418
Page 78 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134419
Page 79 of 272
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134420
Page 80 of 272
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134421
Page 81 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134422
Page 82 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134423
Page 83 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134424
Page 84 of 272
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134425
Page 85 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134426
Page 86 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134427
Page 87 of 272
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134428
Page 88 of 272
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134429
Page 89 of 272
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134430
Page 90 of 272
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134431
Page 91 of 272
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134432
Page 92 of 272
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134433
Page 93 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134434
Page 94 of 272
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134435
Page 95 of 272
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134436
Page 96 of 272
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134437
Page 97 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134438
Page 98 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134439
Page 99 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134440
Page 100 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134441
Page 101 of 272
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134442
Page 102 of 272
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shane
Christensen Approved Mar-08-2021 20:54:16 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134443
Page 103 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-31-2020 14:35:10 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134444
Page 104 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134445
Page 105 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134446
Page 106 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134447
Page 107 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134448
Page 108 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134449
Page 109 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134450
Page 110 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134451
Page 111 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134452
Page 112 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-31-2020 14:54:24 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134453
Page 113 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-22-2020 16:21:46 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134454
Page 114 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Sep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134455
Page 115 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Sep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134456
Page 116 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Sep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134457
Page 117 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Sep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134458
Page 118 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Sep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134459
Page 119 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134460
Page 120 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134461
Page 121 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-22-2020 16:21:46 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134462
Page 122 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:43:25 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134463
Page 123 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134464
Page 124 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134465
Page 125 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134466
Page 126 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.aOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134467
Page 127 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.bOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134468
Page 128 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.cOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134469
Page 129 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.dOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134470
Page 130 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.eOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134471
Page 131 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.fOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134472
Page 132 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.gOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134473
Page 133 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.hOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134474
Page 134 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4.iOct-29-2020 08:43:25 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134475
Page 135 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:43:49 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
FormOct-29-2020 08:36:51 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)
FormOct-28-2020 10:52:42 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134476
Page 136 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
1Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
1Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134477
Page 137 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
2Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
2Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134478
Page 138 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
3Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
3Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134479
Page 139 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
4Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
4Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134480
Page 140 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
5Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
5Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134481
Page 141 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
6Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
6Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134482
Page 142 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
7Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
7Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134483
Page 143 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
8Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
8Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134484
Page 144 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Oct-29-2020 08:43:49 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
9Oct-29-2020 08:36:51 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
9Oct-28-2020 10:52:42 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Done
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134485
Page 145 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:44:01 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134486
Page 146 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 08:44:01 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134487
Page 147 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:44:01 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134488
Page 148 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:44:01 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134489
Page 149 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Oct-29-2020 08:44:01 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134490
Page 150 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:44:15 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134491
Page 151 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 08:44:15 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134492
Page 152 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:44:15 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134493
Page 153 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:44:15 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134494
Page 154 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Oct-29-2020 08:44:15 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134495
Page 155 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:44:28 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134496
Page 156 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.aOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134497
Page 157 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.bOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134498
Page 158 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.cOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134499
Page 159 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.dOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134500
Page 160 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.eOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134501
Page 161 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.fOct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134502
Page 162 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134503
Page 163 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:44:28 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134504
Page 164 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 08:44:43 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134505
Page 165 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 08:44:43 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134506
Page 166 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 08:44:43 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134507
Page 167 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 08:44:43 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134508
Page 168 of 272
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shane
Christensen Approved Mar-08-2021 20:54:16 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Jenessa
Folsom N/A Mar-08-2021 14:50:28 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Mar-06-2021 17:03:27 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Allyson
Christensen N/A Mar-01-2021 10:08:19 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134509
Page 169 of 272
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
N/A
Shane
Christensen Approved Oct-29-2020 17:46:59 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Oct-28-2020 10:51:34 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-23-2020 15:31:02 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134510
Page 170 of 272
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 14:33:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 14:33:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134511
Page 171 of 272
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 14:34:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/31/2020Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134512
Page 172 of 272
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 14:33:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10091135Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 14:33:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 14:34:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 14:34:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 14:34:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
WHITEInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134513
Page 173 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 14:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134514
Page 174 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 14:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 14:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 14:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134515
Page 175 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 14:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:HYSTERECT
OMY
Start Date: UNK/UNK/19
86
Ongoing: NO
End Date:
UNK/UNK
/1986Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
HYSTERECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 14:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1986Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134516
Page 176 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 14:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
1.b
Date Location User Value Reason
Aug-31-2020 14:37:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:ENVIRONMENT
AL ALLERGIES
Start Date: UNK/UNK/1958
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134517
Page 177 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:37:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:37:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
ENVIRONMENTAL ALLERG
IESInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 14:37:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1958Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 14:37:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-31-2020 14:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:MILD AST
HMA
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134518
Page 178 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
MILD ASTHMAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 14:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 14:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-31-2020 14:44:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:OSTEOARTHRI
TIS (GENERALI
ZED)
Start Date
:Jun/UNK/2019Transcription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134519
Page 179 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: YES
Aug-31-2020 14:38:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:OSTEOARTHRI
TIS (GENERALI
ZED)
Start Date
:UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134520
Page 180 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:38:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:38:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
OSTEOARTHRITIS (GENER
ALIZED)Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 14:44:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2019Transcription Error
Aug-31-2020 14:38:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 14:38:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-31-2020 14:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:HYPOTHYR
OIDISMTranscription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134521
Page 181 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: Jun/UNK/201
1
Ongoing: YES
Aug-31-2020 14:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:HYPOTHYR
OIDISM
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134522
Page 182 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
HYPOTHYROIDISMInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-31-2020 14:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2011Transcription Error
Aug-31-2020 14:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-31-2020 14:42:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-31-2020 14:43:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:DEPRESS
IONTranscription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134523
Page 183 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: Jun/UNK/
2011
Ongoing: YES
Aug-31-2020 14:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:DEPRESSI
ON
Start Date: UNK/UNK/
2011
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134524
Page 184 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
DEPRESSIONInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-31-2020 14:43:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2011Transcription Error
Aug-31-2020 14:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2011Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-31-2020 14:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-31-2020 14:43:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:ANXIETYInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134525
Page 185 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: Jun/UNK/2
011
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:43:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:43:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
ANXIETYInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-31-2020 14:43:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2011Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-31-2020 14:43:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-31-2020 14:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134526
Page 186 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Hist
ory Term:MTHFR GENE
MUTATION
Start Date: /1957
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
MTHFR GENE MUTATIONInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-31-2020 14:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
/1957Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-31-2020 14:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-02-2020 13:40:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Line/MH Nu
mber:9Transcription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0134527
Page 187 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Hist
ory Term:ASPIRIN INT
OLERANCE
Start Date: UNK/UNK/19
86
Ongoing: YES
Aug-31-2020 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:ASPIRIN INT
OLERANCE
Start Date: UNK/UNK/19
86
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 04:08:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134528
Page 188 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 13:40:54
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-02-2020 13:40:54
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
ASPIRIN INTOLERANCETranscription
Error
Sep-01-2020 13:36:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 1: Opened DM: A trailing
space is identified.
To avoid
processing errors,
please remove the
identified
character by
deleting the entry
and re-entering the
data (without
using copy and
paste).
Aug-31-2020 14:46:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
ASPIRIN INTOLERANCEInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-31-2020 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1986Initial Entry
1.i Ongoing:
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134529
Page 189 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-31-2020 14:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:GLUTEN INTO
LERANCE
Start Date: UNK/UNK/200
3
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134530
Page 190 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.j Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
GLUTEN INTOLERANCEInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-31-2020 14:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2003Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-31-2020 14:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-31-2020 14:48:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:LACTOSE INT
OLERANCE
Start Date: UNK/UNK/197
0
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134531
Page 191 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.k Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:48:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:48:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
LACTOSE INTOLERANCEInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-31-2020 14:48:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1970Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-31-2020 14:48:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-31-2020 14:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Hist
ory Term:MORPHINE IN
TOLERANCE
Start Date: UNK/UNK/1986
Ongoing: YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134532
Page 192 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.l Line/MH Number:
Date Location User Value Reason
Aug-31-2020 14:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 14:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
MORPHINE INTOLERANCEInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-31-2020 14:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1986Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-31-2020 14:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134533
Page 193 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
243.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
inInitial Entry
6. Body Mass Index:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134534
Page 194 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
41.7Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
FInitial Entry
7.a Temperature Location:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134535
Page 195 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 14:50:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134536
Page 196 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134537
Page 197 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020 14:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Not ApplicableInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134538
Page 198 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 14:54:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 14:54:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
244646Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134539
Page 199 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 14:55:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 14:55:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 15:19:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 14:55:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 14:55:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134540
Page 200 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020 15:19:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GKGInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 15:19:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GKGInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 15:19:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GKHInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 15:19:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GKHInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 15:19:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GKJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 15:19:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GKJInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134541
Page 201 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d
Date Location User Value Reason
Aug-31-2020 15:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BPR980Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 15:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BPR980Initial Entry
5.e
Date Location User Value Reason
Aug-31-2020 15:22:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BPR981Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 15:22:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BPR981Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134542
Page 202 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 15:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 15:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 15:18:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 15:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 15:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134543
Page 203 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020 15:18:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9G29Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 15:18:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9G29Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134544
Page 204 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/31/2020 13:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134545
Page 205 of 272
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 14:56:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134546
Page 206 of 272
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 14:56:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134547
Page 207 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 16:20:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sep/22/2020Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134548
Page 208 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Record Identifier
::1
Temperature: 98.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134549
Page 209 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 16:21:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134550
Page 210 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134551
Page 211 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-22-2020 16:21:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134552
Page 212 of 272
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 16:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 16:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 16:22:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 16:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 16:22:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134553
Page 213 of 272
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-22-2020 16:22:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sample ID: BP9G84Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 16:22:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
BP9G84Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134554
Page 214 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sep/22/2020 16:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134555
Page 215 of 272
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-22-2020 16:23:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134556
Page 216 of 272
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 17:18:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/21/2020Transcription Error
Oct-22-2020 17:13:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/22/2020Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134557
Page 217 of 272
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 17:14:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 17:14:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 17:18:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YES
Date of Collection:
Oct/21/2020Transcription Error
Oct-22-2020 17:14:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 17:14:17
(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-22-2020 17:14:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134558
Page 218 of 272
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct/22/2020
5.a
Date Location User Value Reason
Oct-22-2020 17:14:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sample ID: BR9FNHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 17:14:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
BR9FNHInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 17:16:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sample ID: BKYCYMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 17:16:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
BKYCYMInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 17:17:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sample ID: BKYCVCInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134559
Page 219 of 272
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 17:17:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
BKYCVCInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134560
Page 220 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020 23:02:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Sandip
Namdeorao
Suryawanshi
(pfe.suryas18)Query 5: Closed Visit is marked as
ERRONEOUS
VISIT hence query
closed.
Oct-29-2020 13:13:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 5: Answered Original value is
correct
Oct-29-2020 12:08:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Jennifer Riddle
(pfe riddlj)Query 4: Closed Erroneous visit
Oct-29-2020 10:51:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 3: Deleted Site entered not
applicable.
Oct-29-2020 10:50:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 5: Opened Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-29-2020 10:49:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 4: Opened Erroneous Visit is
marked, but date of
visit is entered.
Please check
whether other
assessments are
performed at this
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134561
Page 221 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
visit.
Oct-29-2020 08:43:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-29-2020 08:39:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check
whether other
assessments are
performed at this
visit.
Oct-29-2020 08:36:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-28-2020 10:52:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:52:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-28-2020 10:51:32
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134562
Page 222 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada) Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-28-2020 10:51:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-28-2020 10:51:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
Oct/28/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Oct-29-2020 08:39:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-28-2020 10:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134563
Page 223 of 272
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/28/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:37:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/28/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:39:42
(UTC-07:00) MountainACV0PFEINFP6000  Dylan
OwenData Entry: Transcription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134564
Page 224 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.dowen)
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: FEVER
Symptom Prese
nt:Not Applica
bleInitial Entry
Oct-29-2020 08:37:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: FEVER
Symptom Present:Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:37:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134565
Page 225 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:Not ApplicableInitial Entry
Oct-29-2020 08:38:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134566
Page 226 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.b Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:38:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:Not ApplicableInitial Entry
Oct-29-2020 08:38:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:Transcription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134567
Page 227 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:38:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: CHILLS
Symptom Prese
nt:Not Applica
bleInitial Entry
Oct-29-2020 08:38:38
(UTC-07:00) MountainACV0PFEINFP6000  Dylan
OwenData Entry:
Symptoms: CHILLSTranscription Error
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134568
Page 228 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.dowen) Symptom Present:
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:Not ApplicableInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134569
Page 229 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020 08:38:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:38:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134570
Page 230 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:Not ApplicableInitial Entry
Oct-29-2020 08:39:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
Oct-29-2020 08:39:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry: Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134571
Page 231 of 272
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/28/2020Form: 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.g
Date Location User Value Reason
Oct-29-2020 08:43:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:Not ApplicableInitial Entry
Oct-29-2020 08:39:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:Transcription Error
Oct-28-2020 10:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
090177e196ae3fa2\Final\Final On: 01-Apr-2021 05:20 
…[truncated]