125742 S1 M5 CRF c4591001 1009 10091123

Document text

Page 1 of 161
***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: 10091123 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
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133953
Page 2 of 161
***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: 10091123 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/27/2020
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133954
Page 3 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10091123]
2.Birth Date: 1947
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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133955
Page 4 of 161
***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: 10091123 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/27/2020
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133956
Page 5 of 161
***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: 10091123 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
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133957
Page 6 of 161
***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: 10091123 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/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133958
Page 7 of 161
***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: 10091123 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:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/1987
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jun/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133959
Page 8 of 161
***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: 10091123 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:[Hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Posterior Septal Resection]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Abnormal discharge uterine cervix]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133960
Page 9 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/1998
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Partial Thyroidectomy]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Thryoid Nodule]
Start Date: UNK/UNK/1975
Ongoing: YES
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133961
Page 10 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ascending colon polyp]
Start Date: Mar/UNK/2020
Ongoing: YES
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133962
Page 11 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [166.0]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [29.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133963
Page 12 of 161
***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: 10091123 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:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133964
Page 13 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [243682]
3.Randomization Group: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133965
Page 14 of 161
***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: 10091123 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/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9GJ8]
5.bSample ID [BP9GJ9]
5.cSample ID [BP9GJB]
5.dSample ID [BPR976]
5.eSample ID [BPR977]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133966
Page 15 of 161
***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: 10091123 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/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9G1L]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133967
Page 16 of 161
***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: 10091123 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/27/2020 14:09
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
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133968
Page 17 of 161
***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: 10091123 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
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133969
Page 18 of 161
***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: 10091123 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/15/2020
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133970
Page 19 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133971
Page 20 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133972
Page 21 of 161
***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: 10091123 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/15/2020
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 [BP9G6H]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133973
Page 22 of 161
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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/15/2020 11:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133974
Page 23 of 161
***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: 10091123 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/13/2020
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133975
Page 24 of 161
***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: 10091123 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/13/2020
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 [BM85Y4]
5.bSample ID [BM85Y5]
5.cSample ID [BM85Y6]
5.dSample ID [BRTSK2]
5.eSample ID [BPR99C]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133976
Page 25 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
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: 10091123 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 Mar/11/2021
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133977
Page 26 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10091123 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:
Mar/11/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSJ4GV]
5.bSample ID [BSJ420]
5.cSample ID [BTWNXY]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133978
Page 27 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133979
Page 28 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133980
Page 29 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133981
Page 30 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133982
Page 31 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
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: 10091123 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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133983
Page 32 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133984
Page 33 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133985
Page 34 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133986
Page 35 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133987
Page 36 of 161
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133988
Page 37 of 161
***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: 10091123 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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133989
Page 38 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133990
Page 39 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133991
Page 40 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133992
Page 41 of 161
***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: 10091123 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/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133993
Page 42 of 161
***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: 10091123 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: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133994
Page 43 of 161
***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: 10091123 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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133995
Page 44 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133996
Page 45 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  TUBULAR ADENOMA OF
ASCENDING COLON Jun/UNK/2020
UNK:UNK NO
End Date Time:
Dec/17/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133997
Page 46 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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)[TUBULAR ADENOMA OF ASCENDING COLON]
4.Start Date Time: Jun/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133998
Page 47 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
[NEW GROWTH]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0133999
Page 48 of 161
***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: 10091123 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 Instance
 1.          Repeating
Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134000
Page 49 of 161
***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: 10091123 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[ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134001
Page 50 of 161
***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: 10091123 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 Da
teForm Instanc
e
 1.1  VACCINATIONS
 NO  SHINGRIX #1
 Oct/17/2
020 Repeating
Pages
 2.2  VACCINATIONS
 NO  SHINGRIX #2
 Jan/12/2
021 Repeating
Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134002
Page 51 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[SHINGRIX #1]
5.Date: Oct/17/2020
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134003
Page 52 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[SHINGRIX #2]
5.Date: Jan/12/2021
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134004
Page 53 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134005
Page 54 of 161
***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: 10091123 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?
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134006
Page 55 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134007
Page 56 of 161
***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: 10091123 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?
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134008
Page 57 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134009
Page 58 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134010
Page 59 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134011
Page 60 of 161
***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: 10091123 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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134012
Page 61 of 161
***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: 10091123 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:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134013
Page 62 of 161
***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: 10091123 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?
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134014
Page 63 of 161
***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: 10091123 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: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134015
Page 64 of 161
***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: 10091123 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: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134016
Page 65 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134017
Page 66 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134018
Page 67 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134019
Page 68 of 161
***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: 10091123 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 [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134020
Page 69 of 161
***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: 10091123 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 Jan/12/2021
2.Erroneous Visit
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134021
Page 70 of 161
***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: 10091123 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 and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134022
Page 71 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134023
Page 72 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134024
Page 73 of 161
***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: 10091123 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: [ ]
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134025
Page 74 of 161
***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: 10091123 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/13/2020
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134026
Page 75 of 161
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134027
Page 76 of 161
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134028
Page 77 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-27-2020 17:38:26 (UTC-07:00)
Mountain Time (US & Canada)Mikaela Jones
(pfe.mjones)Not Applicable
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134029
Page 78 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-28-2020 07:38:35 (UTC-07:00)
Mountain Time (US & Canada)Dylan Owen
(pfe.dowen)na
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134030
Page 79 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-28-2020 07:38:48 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Not Applicable
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134031
Page 80 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-28-2020 07:39:31 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
6.aAug-28-2020 07:38:58 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134032
Page 81 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-28-2020 07:39:31 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
6.aAug-28-2020 07:38:58 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134033
Page 82 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-28-2020 07:39:31 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
6.aAug-28-2020 07:38:58 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)na
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134034
Page 83 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
Colby Bostock  N/A Mar-11-2021 12:07:17 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Mar-06-2021 16:56:48 (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 Feb-24-2021 10:26:07 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-23-2020 13:59:09 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134035
Page 84 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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.
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134036
Page 85 of 161
***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: 10091123 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-27-2020 17:29:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 17:29:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134037
Page 86 of 161
***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: 10091123 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-27-2020 17:38:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/27/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134038
Page 87 of 161
***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: 10091123 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-27-2020 17:29:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10091123Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 17:29:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 17:38:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 17:38:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)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-27-2020 17:38:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
WHITEInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134039
Page 88 of 161
***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: 10091123 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-27-2020 17:38:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Aug/27/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134040
Page 89 of 161
***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: 10091123 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-27-2020 17:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 17:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 17:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134041
Page 90 of 161
***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: 10091123 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-27-2020 17:39:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:39:28
(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-27-2020 17:39:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Gastroesophageal Reflux Diseas
eInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 17:39:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 17:39:28
(UTC-07:00) MountainACV0PFEINFP6000  Mikaela
JonesData Entry:
YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134042
Page 91 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.mjones)
1.b
Date Location User Value Reason
Aug-27-2020 17:39:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Depression
Start Date: UNK/UNK/
1987
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134043
Page 92 of 161
***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: 10091123 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-27-2020 17:39:41
(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-27-2020 17:39:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
DepressionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 17:39:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/1987Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 17:39:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-27-2020 17:39:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypertensio
n
Start Date: Jun/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134044
Page 93 of 161
***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: 10091123 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-27-2020 17:39:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:39:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 17:39:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Jun/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 17:39:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-27-2020 17:40:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Osteoarthriti
s
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134045
Page 94 of 161
***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: 10091123 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-27-2020 17:40:13
(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-27-2020 17:40:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
OsteoarthritisInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-27-2020 17:40:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020 17:40:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-27-2020 17:40:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Hypercholester
olemia
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134046
Page 95 of 161
***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: 10091123 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-27-2020 17:40:29
(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-27-2020 17:40:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
HypercholesterolemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-27-2020 17:40:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-27-2020 17:40:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-27-2020 17:41:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Posterior Septal
Resection
Start Date: UNK/UNK/201
7Transcription Error
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134047
Page 96 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: NO
End Date:
UNK/UNK/
2017
Aug-27-2020 17:40:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Posterior Septa
l Resection
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134048
Page 97 of 161
***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: 10091123 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-27-2020 17:40:46
(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-27-2020 17:40:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Posterior Septal ResectionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-27-2020 17:40:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-27-2020 17:41:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
NO
End Date:
UNK/UNK/2017Transcription Error
Aug-27-2020 17:40:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-27-2020 17:41:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134049
Page 98 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical History
Term:Hysterectomy
Start Date: UNK/UNK/20
19
Ongoing: NO
End Date:
UNK/UNK/
2019
1.g Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:41:14
(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-27-2020 17:41:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
HysterectomyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-27-2020 17:41:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-27-2020 17:41:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134050
Page 99 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h
Date Location User Value Reason
Sep-04-2020 19:18:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Line/MH N
umber:8
Medical Hi
story Term
:Abnormal dischar
ge uterine cervix
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/20
19Transcription Error
Aug-31-2020 14:30:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Abnormal Uterin
e Discharge
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2
019Transcription Error
Aug-27-2020 17:42:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Abnormal Uterin
e Discharge
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2
019Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134051
Page 100 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:42:03
(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 ValueReason
Sep-05-2020
10:00:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
4: Clo
sedDiscrepancy
has been
closed.
Sep-04-2020
19:18:43
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
4: Ans
weredTranscription
Error
Sep-04-2020
19:18:43
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data
Entry
:
Abnor
mal di
scharg
e uteri
ne cer
vixTranscription
Error
Sep-04-2020
10:30:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Jeffrey Signora
TMSQUERY
(pfe.signoj01_tmsquery)Query
4: Rei
ssued:
Opene
dCoding
cannot take
place with the
term as is.
Please update
to further
specify the
term. Are you
reporting
ABNORMAL
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134052
Page 101 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
DISCHARGE
UTERINE
CERVIX?
UTERINE
BLEEDING?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
Sep-02-2020
13:40:00
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query
4: Ans
weredcorrect as is.
this discharge
was unknown
and no further
diagnosis
Sep-01-2020
01:49:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Cavin van Schalkwyk
(pfe.vanscc01)Query
2: Clo
sedResponse
satisfies query
Aug-31-2020
20:43:28
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
4: Ope
nedClarify
ABNORMAL
UTERINE
DISCHARGE
as
follows...Are
you reporting
ABNORMAL
DISCHARGE
UTERINE
CERVIX?
UTERINE
BLEEDING?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134053
Page 102 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Thank you.
Aug-31-2020
20:40:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
3: Clo
sedDiscrepancy
has been
closed.
Aug-31-2020
20:15:06
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
3: Ope
nedClarify
ABNORMAL
UTERINE
DISCHARGE
as
follows...Are
you reporting
ABNORMAL
DISCHARGE
UTERINE
CERVIX?
UTERINE
BLEEDING?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
Thank you.
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134054
Page 103 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-31-2020
18:54:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy
has been
closed.
Aug-31-2020
14:30:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: An
swere
dTranscription
Error
Aug-31-2020
14:30:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data
Entry
:
Abnor
mal U
terine
Disch
argeTranscription
Error
Aug-31-2020
10:58:33
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Swaranjali Subhash
Pawar (pfe.pawars01)Query
2: Op
enedDM: A
trailing space
is identified.
To avoid
processing
errors, please
remove the
identified
character by
deleting the
entry and
re-entering
the data
(without
using copy
and paste).
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134055
Page 104 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
09:11:19
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query
1: An
swere
dthe discharge
was
unknown, not
bleeding and
no diagnosis
associated.
Aug-31-2020
06:07:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Jeffrey Signora
TMSQUERY
(pfe.signoj01_tmsquery)Query
1: Rei
ssued:
Open
edCoding
cannot take
place as is.
Are you
reporting
ABNORMAL
DISCHARGE
UTERINE
CERVIX?
UTERINE
BLEEDING?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
Aug-28-2020
07:38:25
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query
1: An
swere
dno further
clarification,
not ongoing,
hysterectomy
Aug-28-2020
06:58:39
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query
1: Op
enedClarify
ABNORMAL
UTERINE
DISCHARGE
as
follows...Are
you reporting
ABNORMAL
DISCHARGE
UTERINE
CERVIX?
UTERINE
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134056
Page 105 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
BLEEDING?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
Thank you.
Aug-27-2020
17:42:03
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Mikaela Jones
(pfe.mjones)Data
Entry
:
Abnor
mal U
terine
Disch
argeInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-27-2020 17:42:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
UNK/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-27-2020 17:42:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.i
Date Location User Value Reason
Aug-27-2020 19:47:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134057
Page 106 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical History
Term:Post Menopa
usal
Start Date: UNK/UNK/1
998
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Aug-27-2020 19:47:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 19:47:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Post MenopausalInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-27-2020 19:47:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-27-2020 19:47:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-16-2020 21:23:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe 10Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134058
Page 107 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
r:
Medical History
Term:Insomnia
Start Date: UNK/UNK/
2015
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Sep-16-2020 21:23:17
(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
Sep-16-2020 21:23:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
InsomniaInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-16-2020 21:23:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-16-2020 21:23:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-21-2020 12:46:13 ACV0PFEINFP6000  Dylan Data Entry: Transcription Error
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134059
Page 108 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Owen
(pfe.dowen)Line/MH Nu
mber:11
Medical Histo
ry Term:Partial Thyroid
ectomy
Start Date: UNK/UNK/19
75
Ongoing: NO
End Date:
UNK/UNK/
1975
Sep-16-2020 21:23:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Partial Thyroi
dectomy
Start Date: UNK/UNK/19
75
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134060
Page 109 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.k Line/MH Number:
Date Location User Value Reason
Sep-16-2020 21:23:33
(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
Sep-16-2020 21:23:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Partial ThyroidectomyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-16-2020 21:23:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/1975Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-22-2020 18:21:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Closed Response satisfies
query
Sep-21-2020 12:46:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-21-2020 12:46:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
NO
End Date:
UNK/UNK/1975Transcription Error
Sep-20-2020 23:20:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sathenapalli
Suguna
Srujan
(pfe.srujas)Query 1: Opened ClinQuery: Partial
Thyroidectomy: As
this is a procedure,
please can you
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134061
Page 110 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
provide a stop date
Sep-20-2020 18:22:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Candidate ClinQuery: Partial
Thyroidectomy: As
this is a procedure,
please can you
provide a stop date
Sep-16-2020 21:23:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-16-2020 21:23:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12
Medical Histor
y Term:Benign Thryoid
Nodule
Start Date: UNK/UNK/19
75
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134062
Page 111 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.l Line/MH Number:
Date Location User Value Reason
Sep-16-2020 21:23:57
(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
Sep-16-2020 21:23:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Benign Thryoid NoduleInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-16-2020 21:23:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
UNK/UNK/1975Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-16-2020 21:23:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Oct-19-2020 21:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:ascending colo
n polyp
Start Date: Mar/UNK/202
0
Ongoing: YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134063
Page 112 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.m Line/MH Number:
Date Location User Value Reason
Oct-19-2020 21:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 21:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
ascending colon polypInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-19-2020 21:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Mar/UNK/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-19-2020 21:35:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134064
Page 113 of 161
***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: 10091123 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-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
166.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134065
Page 114 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.4Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Record Identifier
::1
Temperature: 99.0
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134066
Page 115 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 17:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134067
Page 116 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 07:38:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020 17:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 17:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 17:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134068
Page 117 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 17:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NOT DONEInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134069
Page 118 of 161
***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: 10091123 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-27-2020 17:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 17:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
243682Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134070
Page 119 of 161
***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: 10091123 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-27-2020 17:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 17:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 17:44:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 17:43:12
(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-27-2020 17:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 17:44:54 ACV0PFEINFP6000  Mikaela Data Entry: Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134071
Page 120 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Jones
(pfe.mjones)Sample ID: BP9GJ8
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 17:44:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BP9GJ8Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 17:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sample ID: BP9GJ9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 17:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BP9GJ9Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 17:45:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sample ID: BP9GJBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 17:45:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BP9GJBInitial Entry
5.d
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134072
Page 121 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-27-2020 17:45:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sample ID: BPR976Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 17:45:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BPR976Initial Entry
5.e
Date Location User Value Reason
Aug-27-2020 17:45:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sample ID: BPR977Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 17:45:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BPR977Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134073
Page 122 of 161
***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: 10091123 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-27-2020 17:43:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 17:43:18
(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-27-2020 17:45:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 17:43:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 17:43:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 17:45:36 ACV0PFEINFP6000  Mikaela Data Entry: Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134074
Page 123 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Jones
(pfe.mjones)Sample ID: BP9G1L
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 17:45:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BP9G1LInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134075
Page 124 of 161
***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: 10091123 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-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 17:43:33
(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-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Aug/27/2020 14:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134076
Page 125 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020 17:43:33
(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-27-2020 17:43:33
(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-27-2020 17:43:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134077
Page 126 of 161
***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: 10091123 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-27-2020 17:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134078
Page 127 of 161
***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: 10091123 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-16-2020 12:29:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134079
Page 128 of 161
***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: 10091123 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-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)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-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134080
Page 129 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 12:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134081
Page 130 of 161
***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: 10091123 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-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134082
Page 131 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-16-2020 12:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NOT DONEInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134083
Page 132 of 161
***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: 10091123 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-16-2020 12:31:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 12:31:13
(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-16-2020 12:31:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
YES
Date of Collection:
Sep/15/2020Transcription Error
Sep-16-2020 12:31:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 12:31:13
(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-16-2020 12:31:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
YESInitial Entry
5.a
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134084
Page 133 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-16-2020 12:31:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sample ID: BP9G6HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 12:31:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
BP9G6HInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134085
Page 134 of 161
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 12:32:05
(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-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
Sep/15/2020 11:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134086
Page 135 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 12:32:05
(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-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 12:32:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YESInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134087
Page 136 of 161
***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: 10091123 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-13-2020 12:08:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Oct/13/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134088
Page 137 of 161
***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: 10091123 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-13-2020 12:09:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 12:09:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 12:09:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 12:09:09
(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-13-2020 12:09:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 12:09:22 ACV0PFEINFP6000  Annjanette Data Entry: Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134089
Page 138 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Kemp
(pfe.akemp)Sample ID: BM85Y4
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 12:09:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BM85Y4Initial Entry
5.b
Date Location User Value Reason
Oct-13-2020 12:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BM85Y5Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 12:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BM85Y5Initial Entry
5.c
Date Location User Value Reason
Oct-13-2020 12:09:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BM85Y6Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 12:09:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BM85Y6Initial Entry
5.d
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134090
Page 139 of 161
***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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-13-2020 12:10:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BRTSK2Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-13-2020 12:10:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BRTSK2Initial Entry
5.e
Date Location User Value Reason
Oct-13-2020 12:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BPR99CInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-13-2020 12:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BPR99CInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134091
Page 140 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 10091123 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
Mar-11-2021 12:08:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Mar/11/2021Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134092
Page 141 of 161
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
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: 10091123 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
Mar-11-2021 12:07:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021 12:07:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021 12:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-11-2021 12:07:17
(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.
Mar-11-2021 12:07:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
YES
Date of Collection:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134093
Page 142 of 161
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021 12:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BSJ4GVInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021 12:07:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BSJ4GVInitial Entry
5.b
Date Location User Value Reason
Mar-11-2021 12:07:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BSJ420Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-11-2021 12:07:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BSJ420Initial Entry
5.c
Date Location User Value Reason
Mar-11-2021 12:07:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BTWNXYInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-11-2021 12:07:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BTWNXYInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134094
Page 143 of 161
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 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
Oct-13-2020 12:10:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 12:10:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 12:10:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134095
Page 144 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Form Created
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134096
Page 145 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
TUBULAR ADENOMA OF AS
CENDING COLONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 16:23:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Query 1: Answered correct as is, sae, no
changes at this time
to be made
Mar-12-2021 14:52:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 2: Answered awaiting unlocking
of medical history
to add it there. It
was also capture on
AE becuase subject
was hospitalized
during the removal,
this met SAE
criteria
Mar-12-2021 02:27:03 ACV0PFEINFP6000  Malerato Query 2: Reissued:Opened DM: Thanks for the
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134097
Page 146 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Moloi
(pfe.moloim)response. Please
clarify if
TUBULAR
ADENOMA OF
ASCENDING
COLON should be
an AE or part of
patients medical
history since it
started before
V1D1VX1L visit
date. If yes, please
review and update
the data as
appropriate. Else,
clarify.
Mar-12-2021 00:32:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Reissued:Opened DM: If event
occurred before
vaccination, please
delete from here
and update as a
Medical History.
Mar-11-2021 17:46:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Query 2: Answered CORRECT AS IS
Mar-11-2021 17:46:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Query 1: Answered CORRECT AS IS
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For TUBULAR
ADENOMA OF
ASCENDING
COLON: Start date
UNK/Jun/2020 is
before V1D1VX1L
visit date 27/Aug
/2020. Please
review and update
as appropriate.
Mar-11-2021 17:45:34
(UTC-07:00) MountainACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start date is before
Consent Date
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134098
Page 147 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) 27/Aug/2020.
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date Time:
Dec/17/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE TUBULAR
ADENOMA OF
ASCENDING
COLON: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-11-2021 17:45:34 ACV0PFEINFP6000  Annjanette Data Entry: Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134099
Page 148 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Kemp
(pfe.akemp)YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134100
Page 149 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
NEW GROWTHInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021 14:50:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered if there were any
prohibited
medications they
would be captured
on the prohibited
medications page
Mar-12-2021 10:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPDCLIN: the
answer to: Was a
Concomitant
Medication given? is
YES. Please clarify
which medications
and if a prohibited
systemic
immunosuppressive
therapy was given,
please also update
PROHIB_CM page.
Else, please clarify.
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134101
Page 150 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 17:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134102
Page 151 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-11-2021 17:47:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Form Created
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134103
Page 152 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-11-2021 17:47:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Form Created
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134104
Page 153 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-11-2021 17:47:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Mar-11-2021 17:47:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-11-2021 17:47:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Mar-12-2021
16:59:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Cl
osedDiscrepancy has
been closed.
Mar-12-2021
14:17:57
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription
Error
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134105
Page 154 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-12-2021
14:17:57
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entr
y:
SHINGRI
X #1Transcription
Error
Mar-12-2021
01:00:37
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: O
penedClarify
SHINGREX #1
as
follows...Should
the spelling be
SHINGRIX #1?
If so, update the
verbatim term as
such. Otherwise
clarify and
update the term
as appropriate or
provide
reference/label.
Thank you.
Mar-11-2021
17:47:06
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entr
y:
SHINGRE
X #1Initial Entry
5. Date:
Date Location User Value Reason
Mar-11-2021 17:47:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Oct/17/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134106
Page 155 of 161
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-11-2021 17:47:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Mar-11-2021 17:47:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-11-2021 17:47:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Mar-12-2021
17:00:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Cl
osedDiscrepancy has
been closed.
Mar-12-2021
14:18:26
(UTC-07:00)
Mountain TimeACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription
Error
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134107
Page 156 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada)
Mar-12-2021
14:18:26
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entr
y:
SHINGRI
X #2Transcription
Error
Mar-12-2021
01:01:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: O
penedClarify
SHINGREX #2
as
follows...Should
the spelling be
SHINGRIX #2?
If so, update the
verbatim term as
such. Otherwise
clarify and
update the term
as appropriate or
provide
reference/label.
Thank you.
Mar-11-2021
17:47:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entr
y:
SHINGRE
X #2Initial Entry
5. Date:
Date Location User Value Reason
Mar-11-2021 17:47:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jan/12/2021Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134108
Page 157 of 161
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
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: 10091123 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
Feb-24-2021 10:26:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Allyson
Christensen
(pfe.achristensen)Data Entry:
Jan/12/2021Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134109
Page 158 of 161
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 10:26:54
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 10:26:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-24-2021 10:26:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Allyson
Christensen
(pfe.achristensen)Data Entry:
Participant is willing to retu
rn for Vaccination 3
Participant is:
eligible and NOT confir
med to have received onl
y placebo at Vaccination
1/2Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134110
Page 159 of 161
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - 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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-24-2021 10:26:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Allyson
Christensen
(pfe.achristensen)Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021 10:26:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Allyson
Christensen
(pfe.achristensen)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134111
Page 160 of 161
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
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: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020 12:10:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020 17:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 17:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-13-2020 12:10:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-27-2020 17:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 17:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134112
Page 161 of 161
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091123 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 11:17:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fa3\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134113