125742 S1 M5 CRF c4591001 1009 10091128

Document text

Page 1 of 228
***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: 10091128 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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134114
Page 2 of 228
***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: 10091128 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/28/2020
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134115
Page 3 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10091128]
2.Birth Date: 1969
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134116
Page 4 of 228
***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: 10091128 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/28/2020
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134117
Page 5 of 228
***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: 10091128 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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134118
Page 6 of 228
***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: 10091128 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/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134119
Page 7 of 228
***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: 10091128 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:[HYPOTHYROIDISM]
Start Date: UNK/UNK/1998
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[KEFLEX ALLERGY-HIVES]
Start Date: Jan/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PENICILLIN ALLERGY-HIVES]
Start Date: Jan/UNK/2019
Ongoing: YES
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134120
Page 8 of 228
***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: 10091128 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:[GASTRIC BYPASS]
Start Date: Jun/UNK/2019
Ongoing: NO
End Date:
Jun/UNK/2019
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBESITY]
Start Date: UNK/UNK/1990
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Back Pain]
Start Date: UNK/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eczema]
Start Date: Jan/UNK/2016
Ongoing: YES
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134121
Page 9 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: Aug/30/2016
Ongoing: YES
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134122
Page 10 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [225.8]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [37.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134123
Page 11 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [69316]
3.Randomization Group: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134124
Page 12 of 228
***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: 10091128 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/28/2020
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 [BP9GJS]
5.bSample ID [BP9GJT]
5.cSample ID [BP9GJV]
5.dSample ID [BPR97J]
5.eSample ID [BPR97K]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134125
Page 13 of 228
***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: 10091128 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/28/2020
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 [BP9G1T]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134126
Page 14 of 228
***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: 10091128 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/28/2020 11:09
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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134127
Page 15 of 228
***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: 10091128 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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134128
Page 16 of 228
***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: 10091128 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/16/2020
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134129
Page 17 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134130
Page 18 of 228
***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: 10091128 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/16/2020
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 [BP9G71]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134131
Page 19 of 228
***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: 10091128 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/16/2020 10:48
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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134132
Page 20 of 228
***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: 10091128 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/14/2020
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134133
Page 21 of 228
***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: 10091128 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/14/2020
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 [BR9FK7]
5.bSample ID [BR9FK8]
5.cSample ID [BR9FK9]
5.dSample ID [BRTSKN]
5.eSample ID [BPR9B0]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134134
Page 22 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134135
Page 23 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/19/2020
2.Date of First Symptom Started: Oct/15/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/24/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134136
Page 24 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Symptoms - Other
5.aSymptoms - Other Text: [chest phlegm]
5.bSymptoms - Other Text: [dizziness]
5.cSymptoms - Other Text: [palpitations]
5.dSymptoms - Other Text: [chest pain]
5.eSymptoms - Other Text: [tachycardia]
5 fSymptoms - Other Text: [dry tongue]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134137
Page 25 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/16/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134138
Page 26 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/16/2020
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: LABCORP COVID-19 RT-PCR TEST Comments
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134139
Page 27 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [CV22803]
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Page 28 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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Page 29 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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FDA-CBER-2021-5683-0134143
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Oct/16/2020
3.Toxicity Grade: 2
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Page 33 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134146
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Page 35 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134148
Page 36 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Page 37 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOL
OGY riverton hospital lab 3741 west
12600 south riverton utah 84065
 Nov/21/
2020 BLOOD
 Sponsor-Defi
ned IdentifierTest:Res
ult:
1  Hemoglobi
n_PX1 16.2
 
2  Hematocrit
_PX2 46.2
 
3  Erythrocyte
s_PX3 4.83
 
5  Platelets_P
X5 204 
7  Leukocytes
_PX7 8.3 
608  Neutrophils
_PX608 4.7 
609  Eosinophils
_PX609 3.1 
612  Monocytes
_PX612 5.9 
610  Basophils_
PX610 0.8 
611  Lymphocyt
es_PX611 2.8 Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134150
Page 38 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [riverton hospital lab 3741 west 12600 south riverton utah 84065]
3.Collection Date: Nov/21/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [16.2]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [46.2]
Not Done:
LNMT Low
[41.0]
High
[53.0]
Unit
%
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134151
Page 39 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.83]
Not Done:
LNMT Low
[4.50]
High
[5.90]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [204]
Not Done:
LNMT Low
[150]
High
[400]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [8.3]
Not Done:
LNMT Low
[3.6]
High
[10.6]
Unit
10^9/L
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134152
Page 40 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.7]
Not Done:
LNMT Low
[1.8]
High
[6.8]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [3.1]
Not Done:
LNMT Low
[0.0]
High
[5.0]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [5.9]
Not Done:
LNMT Low
[2.0]
High
[12.0]
Unit
%
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134153
Page 41 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.8]
Not Done:
LNMT Low
[0.0]
High
[2.0]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.8]
Not Done:
LNMT Low
[1.2]
High
[3.4]
Unit
10^9/L
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134154
Page 42 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134155
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Date: Vital Signs Details Form Instance
 1.Nov/21/2020 Record Identifier: Oxygen Saturation
1  90.0 Repeating Pages
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FDA-CBER-2021-5683-0134157
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/21/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [90.0]
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Page 46 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134159
Page 47 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134160
Page 48 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134161
Page 49 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
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Page 50 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134163
Page 51 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134164
Page 52 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/16/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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 Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134165
Page 53 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10091128 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:
Nov/16/2020
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 [BR9FSJ]
5.bSample ID [BKYD0S]
5.cSample ID [BSJ3H6]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134166
Page 54 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134167
Page 55 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134168
Page 56 of 228
***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: 10091128 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/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0134169
Page 57 of 228
***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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134170
Page 58 of 228
***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: 10091128 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:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134171
Page 59 of 228
***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: 10091128 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 [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134172
Page 60 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134173
Page 61 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134174
Page 62 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134175
Page 63 of 228
***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: 10091128 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[ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134176
Page 64 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134177
Page 65 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134178
Page 66 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134179
Page 67 of 228
***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: 10091128 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?
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134180
Page 68 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134181
Page 69 of 228
***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: 10091128 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?
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134182
Page 70 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134183
Page 71 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134184
Page 72 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134185
Page 73 of 228
***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: 10091128 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:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134186
Page 74 of 228
***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: 10091128 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?
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134187
Page 75 of 228
***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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134188
Page 76 of 228
***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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134189
Page 77 of 228
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134190
Page 78 of 228
***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, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134191
Page 79 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134192
Page 80 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134193
Page 81 of 228
***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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134194
Page 82 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10091128 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/10/2021
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134195
Page 83 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/10/2021
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134196
Page 84 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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 Done
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Done
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134197
Page 85 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134198
Page 86 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10091128 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/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTWNXS]
5.bSample ID [BSJ41S]
5.cSample ID [BSJ4GL]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134199
Page 87 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10091128 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:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9FJ8]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134200
Page 88 of 228
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/10/2021 11:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134201
Page 89 of 228
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134202
Page 90 of 228
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10091128 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 [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134203
Page 91 of 228
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10091128 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?
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134204
Page 92 of 228
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134205
Page 93 of 228
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134206
Page 94 of 228
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134207
Page 95 of 228
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134208
Page 96 of 228
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134209
Page 97 of 228
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 10091128 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: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134210
Page 98 of 228
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134211
Page 99 of 228
***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: 10091128 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/14/2020
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134212
Page 100 of 228
***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: 10091128 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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134213
Page 101 of 228
***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: 10091128 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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134214
Page 102 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-31-2020 09:24:45 (UTC-07:00) Mountain
Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134215
Page 103 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Nov-03-2020 14:18:54 (UTC-07:00) Mountain
Time (US & Canada)Rachel Pugmire
(pfe.rpugmire)
2Oct-23-2020 14:30:45 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Unknown
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134216
Page 104 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Nov-03-2020 14:19:14 (UTC-07:00) Mountain
Time (US & Canada)Rachel Pugmire
(pfe.rpugmire)
3Oct-23-2020 14:30:56 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Unknown
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134217
Page 105 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Oct-27-2020 09:16:50 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)
6Oct-23-2020 14:31:06 (UTC-07:00) Mountain
Time (US & Canada)Dylan Owen
(pfe.dowen)Unknown
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134218
Page 106 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormMar-10-2021 11:59:38 (UTC-07:00) Mountain
Time (US & Canada)Jessica Shaw
(pfe.jshaw)Not Done
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134219
Page 107 of 228
***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: 10091128 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
Jessica Shaw  N/A Mar-10-2021 11:59:17 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Mar-06-2021 17:01:05 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Mar-03-2021 15:55:01 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Feb-22-2021 17:10:21 (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.
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134220
Page 108 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Dylan Owen  N/A Feb-19-2021 16:29:33 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Jan-23-2021 20:16:12 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Jan-19-2021 18:25:50 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Jan-16-2021 13:23:49 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Jan-07-2021 10:23:11 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Jan-06-2021 08:05:41 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134221
Page 109 of 228
***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: 10091128 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.
Dylan Owen  N/A Jan-05-2021 11:05:49 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Jan-01-2021 09:45:07 (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.
Rachel Pugmire  N/A Dec-31-2020 12:59:04 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Dec-31-2020 10:06:19 (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.
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134222
Page 110 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Rachel Pugmire  N/A Dec-31-2020 08:04:28 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Dec-30-2020 09:13:37 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Dec-28-2020 15:45:55 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Nov-25-2020 18:37:25 (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.
Rachel Pugmire  N/A Nov-25-2020 14:59:07 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Nov-16-2020 13:34:28 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134223
Page 111 of 228
***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: 10091128 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.
Dylan Owen  N/A Nov-16-2020 11:38:37 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Nov-04-2020 07:29:27 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Rachel Pugmire  N/A Nov-03-2020 14:09:42 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-29-2020 17:44:09 (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.
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134224
Page 112 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Dylan Owen  N/A Oct-28-2020 16:01:10 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-27-2020 14:19:47 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Dylan Owen  N/A Oct-27-2020 09:16:50 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-23-2020 15:28:15 (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.
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134225
Page 113 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 09:20:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 09:20:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134226
Page 114 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 09:22:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134227
Page 115 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 09:20:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10091128Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 09:20:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1969Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 09:23:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 09:23:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 09:23:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
WHITEInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134228
Page 116 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 09:24:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134229
Page 117 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 09:25:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 09:25:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 09:25:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134230
Page 118 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 09:26:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:HYPOTHYROI
DISM
Start Date: UNK/UNK/199
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:26:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:26:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
HYPOTHYROIDISMInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 09:26:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 09:26:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.b
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134231
Page 119 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 09:27:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:SEASONAL ALL
ERGIES
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:27:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:27:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
SEASONAL ALLERGIESInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 09:27:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 09:27:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-31-2020 09:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134232
Page 120 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Histor
y Term:KEFLEX ALLER
GY-HIVES
Start Date: Jan/UNK/2019
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
KEFLEX ALLERGY-HIVESInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 09:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jan/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 09:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-31-2020 09:28:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:PENICILLIN ALL
ERGY-HIVES
Start Date: Jan/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134233
Page 121 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:28:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:28:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
PENICILLIN ALLERGY-HIVESInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 09:28:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jan/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 09:28:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-31-2020 09:29:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:GASTRIC BYP
ASS
Start Date: Jun/UNK/2019
Ongoing: NO
End Date:
Jun/UNK/20
19Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134234
Page 122 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:29:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:29:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
GASTRIC BYPASSInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-31-2020 09:29:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Jun/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-31-2020 09:29:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
Jun/UNK/2019Initial Entry
1.f
Date Location User Value Reason
Aug-31-2020 09:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:OBESITY
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134235
Page 123 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Aug-31-2020 09:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 09:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
OBESITYInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-31-2020 09:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-31-2020 09:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-17-2020 20:10:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History T
erm:HYPERTENSI
ON
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134236
Page 124 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Sep-17-2020 20:10:19
(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
Sep-17-2020 20:10:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
HYPERTENSIONInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-17-2020 20:10:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-17-2020 20:10:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-14-2020 11:17:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Back Pain
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134237
Page 125 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:17:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:17:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
Back PainInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-14-2020 11:17:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-14-2020 11:17:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-14-2020 11:19:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
Line/MH Number: 9
Medical History Te
rm:Eczema
Start Date: Jan/UNK/20
16
Ongoing: YESTranscription Error
Oct-14-2020 11:18:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:EczemaInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134238
Page 126 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: UNK/UNK/2
016
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:18:37
(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
Oct-14-2020 11:18:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
EczemaInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-14-2020 11:19:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
Jan/UNK/2016Transcription Error
Oct-14-2020 11:18:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
UNK/UNK/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-14-2020 11:18:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-14-2020 11:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Erectile Dysfun
ctionInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134239
Page 127 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: Aug/30/2016
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe kmarti)Data Entry:
Erectile DysfunctionInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134240
Page 128 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.j Start Date:
Date Location User Value Reason
Oct-14-2020 11:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe.kmarti)Data Entry:
Aug/30/2016Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-14-2020 11:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Krista
Marti
(pfe.kmarti)Data Entry:
YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134241
Page 129 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
225.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.6Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134242
Page 130 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 09:30:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134243
Page 131 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 09:31:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 09:31:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
69316Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134244
Page 132 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 09:31:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 09:31:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 09:33:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 09:31:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-31-2020 09:31:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 09:33:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GJSInitial Entry
5.a Sample ID
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134245
Page 133 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 09:33:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GJSInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 09:34:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GJTInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 09:34:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GJTInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 09:34:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GJVInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 09:34:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GJVInitial Entry
5.d
Date Location User Value Reason
Aug-31-2020 09:34:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BPR97JInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134246
Page 134 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 09:34:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BPR97JInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020 09:34:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BPR97KInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 09:34:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BPR97KInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134247
Page 135 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 09:35:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 09:35:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 09:35:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 09:35:12
(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-31-2020 09:35:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 09:35:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9G1TInitial Entry
5.a Sample ID
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134248
Page 136 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020 09:35:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9G1TInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134249
Page 137 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/28/2020 11:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
LEFTInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134250
Page 138 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Route:
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 09:36:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134251
Page 139 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 09:36:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Annjanette
Kemp
(pfe.akemp)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134252
Page 140 of 228
***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: 10091128 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 11:32:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Sep/16/2020Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134253
Page 141 of 228
***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: 10091128 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 11:32:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 11:32:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 11:32:25
(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 11:32:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020 11:32:25
(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
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134254
Page 142 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-16-2020 11:32:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134255
Page 143 of 228
***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: 10091128 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 11:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 11:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 11:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 11:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-16-2020 11:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 11:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Sample ID: BP9G71Initial Entry
5.a Sample ID
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134256
Page 144 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-16-2020 11:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
BP9G71Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134257
Page 145 of 228
***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: 10091128 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 11:32:49
(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 11:32:49
(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 11:32:49
(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 11:32:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Sep/16/2020 10:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 11:32:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020 11:32:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
LEFTInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134258
Page 146 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Route:
Date Location User Value Reason
Sep-16-2020 11:32:49
(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 11:32:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 11:32:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134259
Page 147 of 228
***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: 10091128 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-14-2020 10:32:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe mjones)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134260
Page 148 of 228
***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: 10091128 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-14-2020 10:32:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 10:32:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 10:34:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 10:32:42
(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-14-2020 10:32:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mikaela
Jones
(pfe.mjones)Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 10:34:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
Sample ID: BR9FK7Initial Entry
5.a Sample ID
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134261
Page 149 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-14-2020 10:34:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
BR9FK7Initial Entry
5.b
Date Location User Value Reason
Oct-14-2020 10:34:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
Sample ID: BR9FK8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 10:34:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
BR9FK8Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020 10:34:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
Sample ID: BR9FK9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 10:34:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
BR9FK9Initial Entry
5.d
Date Location User Value Reason
Oct-14-2020 10:35:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
Sample ID: BRTSKNInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134262
Page 150 of 228
***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: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Oct-14-2020 10:35:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
BRTSKNInitial Entry
5.e
Date Location User Value Reason
Oct-14-2020 10:35:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
Sample ID: BPR9B0Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-14-2020 10:35:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jenessa
Folsom
(pfe.jfolsom)Data Entry:
BPR9B0Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134263
Page 151 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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-19-2020 19:45:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-19-2020 19:43:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as
appropriate.
Oct-19-2020 19:43:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Oct-19-2020 19:43:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/19/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-19-2020 19:43:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134264
Page 152 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/19/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Oct/15/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-03-2021 15:55:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
NO
Date of Last Symptom Resolve
d:
Feb/24/2021Transcription Error
Feb-21-2021 23:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 2: Closed Response satisfies
query
Feb-19-2021 15:02:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 2: Answered ongoing
Feb-15-2021 03:56:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bembem
Takhellambam
(pfe.takheb)Query 2: Opened DM:Please confirm
the symptoms are
still ongoing for this
COVID Illness. If all
symptoms for this
illness are resolved;
please update the
Last Symptoms
Resolved Date else
clarify. Thanks
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134265
Page 153 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-08-2021 10:15:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vrunda Parikh
(pfe.parikv06)Query 1: Closed Response satisfies
query
Jan-07-2021 10:23:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered yes, ongoing
Jan-05-2021 11:56:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vrunda Parikh
(pfe.parikv06)Query 1: Opened CLINQUERY:
Please clarify
whether the reported
symptoms are still
ongoing? If
symptoms have
ended, please update
‘Symptoms
Ongoing’ on to ‘NO’
and add Date of Last
Symptom Resolved
on the CRF.
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134266
Page 154 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.b
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-16-2020 12:07:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BRE
ATH
Sympto
m Prese
nt:YESNew Information
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BRE
ATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134267
Page 155 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.c Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED SHORTNE
SS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-16-2020 12:07:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESNew Information
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Oct-19-2020 19:45:01 ACV0PFEINFP6000  Dylan Data Entry: Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134268
Page 156 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-07:00) Mountain
Time (US & Canada)Owen
(pfe.dowen)Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:YESInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134269
Page 157 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.g
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134270
Page 158 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.h Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-19-2020 19:45:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-16-2020 12:07:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms - Other: chest phlegmInitial Entry
5.a Symptoms - Other Text:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134271
Page 159 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-16-2020 12:07:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
chest phlegmInitial Entry
5.b
Date Location User Value Reason
Dec-28-2020 15:45:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms - Other: dizzinessInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-28-2020 15:45:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
dizzinessInitial Entry
5.c
Date Location User Value Reason
Dec-28-2020 15:46:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms - Other: palpitationsInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-28-2020 15:46:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
palpitationsInitial Entry
5.d
Date Location User Value Reason
Dec-28-2020 15:46:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Symptoms - Other: chest painInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134272
Page 160 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Symptoms - Other Text:
Date Location User Value Reason
Dec-28-2020 15:46:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
chest painInitial Entry
5.e
Date Location User Value Reason
Dec-31-2020 08:04:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Symptoms - Other: tachycardiaInitial Entry
5.e Symptoms - Other Text:
Date Location User Value Reason
Dec-31-2020 08:04:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
tachycardiaInitial Entry
5.f
Date Location User Value Reason
Dec-31-2020 08:05:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Symptoms - Other: dry tongueInitial Entry
5.f Symptoms - Other Text:
Date Location User Value Reason
Dec-31-2020 08:05:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
dry tongueInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134273
Page 161 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-19-2020 19:45:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Form Created
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134274
Page 162 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-23-2020 14:46:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephen
Paolini
(pfe.paolis01)Query 1: Closed Response satisfies
query
Oct-23-2020 14:31:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered records were
received and the
requested
information was not
provided
Oct-23-2020 14:28:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephen
Paolini
(pfe.paolis01)Query 1: Reissued:Opened CLIQUERY: Please
complete missing
fields on CRF.
Please provide query
response when data
entered.
Oct-23-2020 12:57:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered ok
Oct-21-2020 12:57:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephen
Paolini
(pfe.paolis01)Query 1: Reissued:Opened CLIQUERY: Please
complete missing
fields on CRF.
Please provide query
response when data
entered.
Oct-21-2020 09:49:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered unknown
information
Oct-20-2020 19:29:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephen
Paolini
(pfe.paolis01)Query 1: Opened CLIQUERY: Please
complete missing
fields on CRF.
Oct-19-2020 19:45:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
Oct/16/2020Initial Entry
2. Specimen Type:
Date Location User ValueReason
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134275
Page 163 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-03-2020
16:35:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Erica Weaver
(pfe.weavee01)Query
1: Clo
sedupdated.
Nov-03-2020
14:19:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Rachel Pugmire
(pfe.rpugmire)Data
Entry
:
SWA
BBE
D MA
TERI
ALInitial Entry
Nov-03-2020
14:18:54
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Rachel Pugmire
(pfe.rpugmire)Data
Entry
:Initial Entry
Nov-03-2020
13:28:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Mikaela Jones
(pfe.mjones)Query
1: An
swere
dOriginal value is correct
Nov-03-2020
11:52:12
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query
1: Op
enedDMW5245770;Specimen
Type is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-03-2020
11:49:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Can
didateDMW5245770;Specimen
Type is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Oct-23-2020
14:30:45
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data
Entry
:
Unkn
ownInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134276
Page 164 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada)
3. Specimen Collection Location:
Date Location User ValueReason
Nov-03-2020
16:36:11
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Erica Weaver
(pfe.weavee01)Query
1: Clo
sedupdated.
Nov-03-2020
14:19:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Rachel Pugmire
(pfe.rpugmire)Data
Entry
:
NAS
OPH
ARY
NXInitial Entry
Nov-03-2020
14:19:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Rachel Pugmire
(pfe.rpugmire)Data
Entry
:Initial Entry
Nov-03-2020
13:28:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Mikaela Jones
(pfe.mjones)Query
1: An
swere
dOriginal value is correct
Nov-03-2020
11:48:26
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query
1: Op
enedDMW5246467;Specimen
Collection Location is
not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-03-2020
11:47:13
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Can
didateDMW5246467;Specimen
Collection Location is
not expected to be
Unknown or Not
Applicable. Please
review and update
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134277
Page 165 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
appropriately or clarify
Oct-23-2020
14:30:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data
Entry
:
Unkn
ownInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-19-2020 19:45:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-19-2020 19:45:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-03-2020 15:11:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-03-2020 15:10:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Trade Name is not
Other, however
Trade Name Other,
Specify is
completed. Please
verify and correct
inconsistency.
Nov-03-2020 15:10:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry:
LABCORP COVID-19 RT-PCR
TESTTranscription Error
Nov-03-2020 14:10:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134278
Page 166 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-03-2020 14:09:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Trade Name is Other,
however Trade
Name Other, Specify
is not completed.
Please update.
Oct-27-2020 11:11:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query 2: Closed Response satisfies
query
Oct-27-2020 10:41:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 2: Answered I changed it to other
per the last query.
The test is unknown
and that is what was
originally captured
Oct-27-2020 10:38:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query 2: Reissued:Opened Trade Name is Other,
however Trade
Name Other, Specify
is not completed.
Please update.
Oct-27-2020 10:37:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vrunda Parikh
(pfe.parikv06)Query 1: Closed Response satisfies
query
Oct-27-2020 09:17:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 2: Answered Changed data per
query
Oct-27-2020 09:17:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Trade Name is Other,
however Trade
Name Other, Specify
is not completed.
Please update.
Oct-27-2020 09:17:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-27-2020 09:17:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
OTHERInitial Entry
Oct-27-2020 09:16:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry: Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134279
Page 167 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-26-2020 14:07:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vrunda Parikh
(pfe.parikv06)Query 1: Opened CLINQUERY: Per
CRF CG section
8.31. if appropriate
Trade Name is not
available in the
pre-defined list and
unknown, please
select ‘OTHER’ for
Trade Name.
Oct-23-2020 14:31:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
UnknownInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-19-2020 19:45:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
POSITIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-03-2020 14:09:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry: Transcription Error
Oct-21-2020 09:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
clia certified labInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-03-2020 15:11:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry: Transcription Error
Nov-03-2020 14:10:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry:
labcorp COVID-19 RT-PCRInitial Entry
Nov-03-2020 14:09:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry: Transcription Error
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134280
Page 168 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020 06:40:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vikas Joshi
(pfe.joshiv22)Query 2: Closed Response satisfies
query
Oct-28-2020 16:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-28-2020 16:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
NALT unknownTranscription Error
Oct-28-2020 05:20:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Derrick
Newton
(pfe newtod07)Query 1: Closed Duplicate.
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134281
Page 169 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-28-2020
05:20:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 2: O
penedAs per CRF
CR, If trade
name is not
known. Please
update "NALT
Unknown" in
the specified
field, Thank
you.
"[newtod07
SDQ=25754]"
Oct-28-2020
05:18:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Derrick Newton
(pfe.newtod07)Query 1: O
penedDM: As per
CRF CR
Section 8.31.7,
If the Trade
Name is not
known, please
enter “NALT
Unknown” in
the specified
field, Thank
you.
Oct-27-2020
12:30:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry
:
unknownInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134282
Page 170 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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-19-2020 19:45:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 19:45:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 11:26:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Christopher
Lewis
(pfe.lewisc45)Query 2: Closed Response satisfies
query
Oct-21-2020 09:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-21-2020 09:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
YES
Date of Collection:
Oct/20/2020Transcription Error
Oct-21-2020 09:49:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 16:11:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Christopher
Lewis
(pfe.lewisc45)Query 2: Opened Per source
documents date of
collection is
20OCT2020.
Oct-20-2020 08:49:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134283
Page 171 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
correct as
appropriate.
Oct-19-2020 19:45:56
(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-19-2020 19:45:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
YES
Date of Collection:
Oct/18/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 09:49:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sample ID: CV22803Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 09:49:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
CV22803Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134284
Page 172 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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-19-2020 19:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 19:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 19:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-19-2020 19:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
self swab collectedInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134285
Page 173 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-31-2020 12:59:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contacts
:
1Transcription Error
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134286
Page 174 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 12:59:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
YES
Number of Visits or Contacts:
1Transcription Error
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Dec-31-2020 13:00:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1New Information
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134287
Page 175 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-31-2020 13:00:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
YES
Number of Visits or Contacts:
1New Information
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134288
Page 176 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of V
isits or Contacts
:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134289
Page 177 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-19-2020 19:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134290
Page 178 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-19-2020 19:47:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-21-2020
11:42:37
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Close
dDiscrepancy has
been closed.
Oct-21-2020
09:50:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription Error
Oct-21-2020
09:50:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
YES
Respiratory Il
lness Diagnos
is:
COVID-19
Date of Diagn
osis:
Oct/16/2020Transcription Error
Oct-20-2020
00:49:47
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Open
edClarify COVID as
follows...The term
is unclear and
appears truncated.
Are you reporting
CORONAVIRUS
INFECTION
DISEASE?
COVID-19?
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134291
Page 179 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
COVID-19
VIRUS TEST?
COVID-19
SUSPECTED? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
verbatim
accordingly. Thank
you.
Oct-19-2020
19:47:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
YES
Respiratory Il
lness Diagnos
is:
COVID
Date of Diagn
osis:
Oct/16/2020Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 19:47:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
2Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134292
Page 180 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rachel
Pugmire
(pfe rpugmire)Form Created
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134293
Page 181 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 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
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Jan-25-2021 06:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Madhan Babu
(pfe.babum05)Query 1: Closed Closing as issue not
found in report dated
25Jan2021.
Jan-21-2021 23:05:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ananta Gogoi
(pfe.gogoia)Query 1: Reissued:Candidate To be followed up
by Triad
Jan-21-2021 15:08:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered I already tried that,
stop querying this
Jan-20-2021 00:49:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Reissued:Opened DM: A carriage is
still being identified,
please delete the
entry and re-enter
the data (without
using copy and
paste).
Jan-19-2021 18:25:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-19-2021 18:25:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
riverton hospital lab 3741 west 1
2600 south riverton utah 84065Transcription Error
Jan-08-2021 03:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe mahadp07)Query 1: Reissued:Opened DM2: Thank you for
response. However
for this field,
carriage is still
identified. To avoid
processing errors,
please remove the
identified character
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134294
Page 182 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
by deleting the entry
and re-entering the
data (without using
copy and paste).
Jan-07-2021 10:23:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-07-2021 10:23:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
RIVERTON HOSPITAL LAB
3741 w 12600 S RIVERTON UT
AH 84065Transcription Error
Jan-05-2021 22:24:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Vikas Joshi
(pfe.joshiv22)Query 1: Reissued:Opened DM1: Thanks for
the update but the
carriage return still
exists. Please
remove all data and
type enter again
without using copy
paste function and
without any special
characters. Please
update and confirm.
Jan-05-2021 11:05:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-05-2021 11:05:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
RIVERTON HOSPITAL-LAB
3741 w 12600 S RIVERTON, UT
AH 84065Transcription Error
Jan-04-2021 12:29:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM :A carriage
return is identified,
please do not press
enter key, just type
lab name all in
single line with
comma separated.
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe rpugmire)Data Entry:
RIVERTON HOSPITAL -LAB
3741 w 12600 S RIVERTON, UT
AH 84065Initial Entry
3. Collection Date:
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134295
Page 183 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Nov/21/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:1
Test:: Hemoglobin_
PX1
Result:: 16.2
Not Done::
Lab Normal Range: Low
13.5
High
17.5
Unit
g/dLInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) MountainACV0PFEINFP6000  Rachel
PugmireData Entry:
Hemoglobin_PX1Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134296
Page 184 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.rpugmire)
5.a Result:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
16.2Initial Entry
5.a LNMT
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Low
13.5
High
17.5
Unit
g/dLInitial Entry
5.b
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:2
Test:: Hematocrit_
PX2
Result:: 46.2
Not Done::
Lab Normal Range: Low
41.0
High
53.0
Unit
%Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134297
Page 185 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Sponsor ID:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
46.2Initial Entry
5.b LNMT
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Low
41.0
High
53.0
Unit
%Initial Entry
5.c
Date Location User Value Reason
Jan-21-2021 15:15:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sponsor-Defined Id
entifier:3
Test:: Erythrocytes
_PX3
Result:: 4.83Transcription Error
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134298
Page 186 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done::
Lab Normal Range
:Low
4.50
High
5.90
Unit
10^12/L
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:3
Test:: Erythrocytes
_PX3
Result:: 4.83
Not Done::
Lab Normal Range
:Low
4.50
High
5.90Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134299
Page 187 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sponsor ID:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Erythrocytes_PX3Initial Entry
5.c Result:
Date Location User Value Reason
Jan-22-2021 00:02:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Amol Shinde
(pfe.shinda18)Query 1: Closed Response satisfies
query
Jan-21-2021 15:15:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Jan-08-2021 01:58:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Kindly connect
with your CRA for
any further
assistance if needed
and update CRF as
appropriate. Else
clarify.
Jan-07-2021 10:21:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered these are the only
units that I have. I
cannot select from
the available units
Jan-05-2021 22:25:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Please review
and consider to
select the ranges
with available unit
from the CRF
options. Else
connect with your
CRA for any further
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134300
Page 188 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
assistance if needed.
Jan-05-2021 11:06:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered you want me to
convert the units?
Jan-03-2021 21:29:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Thank you for
the response. Please
consider to update
the ranges with
available unit from
the CRF options.
Kindly connect with
your CRA for any
further assistance if
needed.
Dec-31-2020 08:46:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Query 1: Answered unit unavailable
K/mcL
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal range
(Low, high or Unit)
is missing. Please
correct or confirm.
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
4.83Initial Entry
5.c LNMT
Date Location User Value Reason
Jan-21-2021 15:15:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Data Entry:
Low
4.50
High
5.90
Unit
10^12/LTranscription Error
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Low
4.50Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134301
Page 189 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
High
5.90
5.d
Date Location User Value Reason
Jan-21-2021 15:19:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan
Owen
(pfe.dowen)Data Entry:
Sponsor-Defined Ide
ntifier:5
Test:: Platelets_P
X5
Result:: 204
Not Done::
Lab Normal Range: Low
150
High
400
Unit
10^9/LTranscription Error
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:5
Test:: Platelets_P
X5
Result:: 204
Not Done::
Lab Normal Range: Low
150
High
400Initial Entry
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134302
Page 190 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sponsor ID:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
Platelets_PX5Initial Entry
5.d Result:
Date Location User Value Reason
Jan-22-2021 00:47:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Minal Pathak
(pfe.patham13)Query 1: Closed Unit updated.
Jan-21-2021 15:19:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Jan-08-2021 01:59:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Kindly connect
with your CRA for
any further
assistance if needed
and update CRF as
appropriate. Else
clarify.
Jan-07-2021 10:21:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered these are the only
units that I have. I
cannot select from
the available units
Jan-05-2021 22:25:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Please review
and consider to
select the ranges
with available unit
from the CRF
options. Else
connect with your
CRA for any further
090177e196ae3fa1\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134303
Page 191 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South
Subject No: 10091128 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
assistance if needed.
Jan-05-2021 11:06:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dylan Owen
(pfe.dowen)Query 1: Answered not available
Jan-03-2021 21:30:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM: Thank you for
the response. Please
consider to update
the ranges with
available unit from
the CRF options.
Kindly connect with
your CRA for any
further assistance if
needed.
Dec-31-2020 08:47:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Query 1: Answered unit unavailable
K/mcL
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal range
(Low, high or Unit)
is missing. Please
correct or confirm.
Dec-31-2020 08:38:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pugmire
(pfe.rpugmire)Data Entry:
204Initial Entry
5.d LNMT
Date Location User Value Reason
Jan-21-2021 15:19:12
(UTC-07:00) Mountain
Time (US & Cana
…[truncated]