Document text
Page 1 of 205
***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: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134614
Page 2 of 205
***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: 10091149 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
Sep/3/2020
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134615
Page 3 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10091149]
2.Birth Date: 1944
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134616
Page 4 of 205
***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: 10091149 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/3/2020
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134617
Page 5 of 205
***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: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134618
Page 6 of 205
***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: 10091149 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
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134619
Page 7 of 205
***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: 10091149 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:[MYOCARDIAL INFARCTION]
Start Date: Apr/23/2019
Ongoing: NO
End Date:
Apr/23/2019
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN PROSTATIC HYPERPLASIA]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134620
Page 8 of 205
***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: 10091149 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:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/1995
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: UNK/UNK/1985
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSCILLPSIA]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INSOMNIA]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134621
Page 9 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LOW BACK PAIN]
Start Date: UNK/UNK/2015
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HISTORY OF SPINAL MENINGITIS-NO SYMPTOMS TODAY]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2018
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[AUGMENTIN INTOLERANCE]
Start Date: UNK/UNK/2017
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SLEEP APNEA]
Start Date: Mar/31/2012
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134622
Page 10 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACTINIC KERATOSIS]
Start Date: UNK/UNK/2010
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HISTORY OF DIVERTICULITIS-NO SYMPTOMS]
Start Date: UNK/UNK/2010
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT HIP PAIN]
Start Date: UNK/UNK/2014
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT SHOULDER PAIN]
Start Date: Aug/19/2011
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134623
Page 11 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ARTHRITIS OF CARPOMETACARPAL JOINT LEFT THUMB]
Start Date: UNK/UNK/2019
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL IMPACTED CERUM OF EARS-INTERMITTENT]
Start Date: UNK/UNK/2000
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Clostridium difficile Infection]
Start Date: Apr/10/2019
Ongoing: NO
End Date:
May/UNK/2019
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TRIGGER FINGER LEFT HAND]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2020
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134624
Page 12 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diverticulosis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atherosclerosis of aorta]
Start Date: Apr/23/2019
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[coronary artery disease]
Start Date: Apr/23/2019
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134625
Page 13 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [164.6]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [22.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134626
Page 14 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [249592]
3.Randomization Group: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134627
Page 15 of 205
***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: 10091149 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:
Sep/3/2020
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 [BP9GLP]
5.bSample ID [BP9GLR]
5.cSample ID [BP9GLS]
5.dSample ID [BRTSDH]
5.eSample ID [BRTS80]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134628
Page 16 of 205
***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: 10091149 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/3/2020
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 [BP9G3N]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134629
Page 17 of 205
***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: 10091149 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/3/2020 11:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134630
Page 18 of 205
***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: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134631
Page 19 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134632
Page 20 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134633
Page 21 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9G83]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134634
Page 22 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 10:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134635
Page 23 of 205
***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: 10091149 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/20/2020
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134636
Page 24 of 205
***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: 10091149 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/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 [BR9FMF]
5.bSample ID [BKYCY0]
5.cSample ID [BKYCTK]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134637
Page 25 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134638
Page 26 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134639
Page 27 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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 [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134640
Page 28 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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 [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134641
Page 29 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134642
Page 30 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134643
Page 31 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134644
Page 32 of 205
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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 [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134645
Page 33 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134646
Page 34 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134647
Page 35 of 205
***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: 10091149 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134648
Page 36 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134649
Page 37 of 205
***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: 10091149 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:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134650
Page 38 of 205
***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: 10091149 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 [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134651
Page 39 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 worsening of dive
rticulitis Dec/31/2020 UN
K:UNK NO
End Date Time:
Jan/2/2021 UNK:UN
K
Repeating
Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134652
Page 40 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[worsening of diverticulitis]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/2/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134653
Page 41 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[underlying illness]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021051741]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134654
Page 42 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication E
rrorStart D
ateIs the medication error Stil
l OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134655
Page 43 of 205
***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: 10091149 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[ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134656
Page 44 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1.1 VACCINATION
S NO influenza vac
cine Oct/8/2
020 Repeating
Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134657
Page 45 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[influenza vaccine]
5.Date: Oct/8/2020
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134658
Page 46 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134659
Page 47 of 205
***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: 10091149 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?
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134660
Page 48 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134661
Page 49 of 205
***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: 10091149 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?
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134662
Page 50 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134663
Page 51 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134664
Page 52 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134665
Page 53 of 205
***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: 10091149 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:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134666
Page 54 of 205
***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: 10091149 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?
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134667
Page 55 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134668
Page 56 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134669
Page 57 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134670
Page 58 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134671
Page 59 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134672
Page 60 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134673
Page 61 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134674
Page 62 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 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/15/2021
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134675
Page 63 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
Feb/15/2021
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134676
Page 64 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134677
Page 65 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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 :Feb/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134678
Page 66 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 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:
Feb/15/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6208]
5.bSample ID [BSJ3YL]
5.cSample ID [BSJ4B4]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134679
Page 67 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 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:
Feb/15/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9FFR]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134680
Page 68 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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: Feb/15/2021 09:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134681
Page 69 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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/8/2021
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134682
Page 70 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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/8/2021
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 [BR9FJ7]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134683
Page 71 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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/8/2021 09:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134684
Page 72 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134685
Page 73 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134686
Page 74 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134687
Page 75 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134688
Page 76 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134689
Page 77 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134690
Page 78 of 205
***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: 10091149 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: [ ]
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134691
Page 79 of 205
***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: 10091149 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/20/2020
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134692
Page 80 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134693
Page 81 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shane
Christensen Approved Mar-08-2021 20:54:57 (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.
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134694
Page 82 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-03-2020 15:54:55 (UTC-07:00)
Mountain Time (US & Canada)Annjanette
Kemp
(pfe.akemp)Not Applicable
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134695
Page 83 of 205
***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, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-15-2021 10:39:52 (UTC-07:00)
Mountain Time (US & Canada)Madison Ellis
(pfe.mellis)Not Applicable
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134696
Page 84 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shane
Christensen Approved Mar-08-2021 20:54:57 (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.
Madison Ellis N/A Mar-08-2021 10:33:52 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Mar-06-2021 17:06:58 (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.
Annjanette
Kemp N/A Feb-26-2021 15:41:34 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134697
Page 85 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
N/A
Shane
Christensen Approved Feb-22-2021 17:18:12 (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.
Madison Ellis N/A Feb-15-2021 10:33:04 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Feb-13-2021 21:24:44 (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 Feb-11-2021 08:18:47 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134698
Page 86 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Shane
Christensen Approved Jan-25-2021 20:51:34 (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.
Ricell Ann
Piojo N/A Jan-25-2021 03:26:41 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Jan-23-2021 20:19:10 (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-21-2021 10:17:43 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-29-2020 17:49:35 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134699
Page 87 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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 Oct-27-2020 09:57:18 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shane
Christensen Approved Oct-23-2020 13:51:48 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShaneChristensen, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134700
Page 88 of 205
***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: 10091149 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
Sep-03-2020 15:54:21
(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
Sep-03-2020 15:54:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134701
Page 89 of 205
***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: 10091149 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
Sep-03-2020 15:54:27
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Sep/3/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134702
Page 90 of 205
***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: 10091149 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
Sep-03-2020 15:54:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10091149Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 15:54:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 15:54:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 15:54:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 15:54:37
(UTC-07:00)ACV0PFEINFP6000 Annjanette
KempData Entry:
WHITEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134703
Page 91 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US &
Canada)(pfe.akemp)
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134704
Page 92 of 205
***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: 10091149 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-03-2020 15:54:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134705
Page 93 of 205
***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: 10091149 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
Sep-03-2020 15:55:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 15:55:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 15:55:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134706
Page 94 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 15:57:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:MYOCARDIAL
INFARCTION
Start Date: Apr/23/2019
Ongoing: NO
End Date:
Apr/23/2019Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:57:18
(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
Feb-03-2021
16:07:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Query closed; will
follow for updated
Carvedilol
indication
information.
Feb-03-2021
15:55:42
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered I did not add HTN
to medical histort,
I amended the
indication for the
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134707
Page 95 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada) medication.
Correct as is
Feb-02-2021
09:33:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical Thank
you; please also
add HTN on this
Past Med Hx CRF
Feb-01-2021
15:51:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered updated on sae
form
Jan-27-2021 15:14:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical SAE
report states
subject is
receiving
carvedilol for
Hypertension;
however, HTN is
not recorded on
past Med hx here
or on SAE report.
Please update
with past med Hx
in both locations
Sep-03-2020
15:57:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
MYOCARDIAL INFARC
TIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 15:57:18
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Apr/23/2019Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134708
Page 96 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada)
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 15:57:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
Apr/23/2019Initial Entry
1.b
Date Location User Value Reason
Sep-03-2020 15:58:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:GASTROESOPH
AGEAL REFLUX
DISEASE
Start Dat
e:UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134709
Page 97 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:58:03
(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
Sep-03-2020 15:58:03
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
GASTROESOPHAGEAL R
EFLUX DISEASEInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 15:58:03
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 15:58:03
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-03-2020 15:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134710
Page 98 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical History
Term:DEPRESSI
ON
Start Date: UNK/UNK/
1990
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:59:37
(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
Sep-03-2020 15:59:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
DEPRESSIONInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 15:59:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 15:59:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134711
Page 99 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d
Date Location User Value Reason
Sep-03-2020 16:00:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:BENIGN PROST
ATIC HYPERPL
ASIA
Start Date
:UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134712
Page 100 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:00:31
(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
Sep-03-2020 16:00:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BENIGN PROSTATIC HYP
ERPLASIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 16:00:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1995Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 16:00:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 16:01:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134713
Page 101 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Histo
ry Term:HYPERLIPI
DEMIA
Start Date: UNK/UNK/1
995
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:01:00
(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
Sep-03-2020 16:01:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
HYPERLIPIDEMIAInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020 16:01:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1995Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020 16:01:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134714
Page 102 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f
Date Location User Value Reason
Sep-03-2020 16:02:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:HYPOTHYR
OIDISM
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134715
Page 103 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:02:10
(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
Sep-03-2020 16:02:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
HYPOTHYROIDISMInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020 16:02:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/1985Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020 16:02:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-03-2020 16:02:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134716
Page 104 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical History
Term:OSCILLPS
IA
Start Date: UNK/UNK/
2017
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:02:57
(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-03-2020 16:02:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
OSCILLPSIAInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-03-2020 16:02:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-03-2020 16:02:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134717
Page 105 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h
Date Location User Value Reason
Sep-03-2020 16:03:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:INSOMNI
A
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134718
Page 106 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:03:23
(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
Sep-03-2020 16:03:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
INSOMNIAInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-03-2020 16:03:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-03-2020 16:03:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-03-2020 16:04:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134719
Page 107 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Histor
y Term:LOW BACK
PAIN
Start Date: UNK/UNK/
2015
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:04:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:04:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
LOW BACK PAINInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-03-2020 16:04:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-03-2020 16:04:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134720
Page 108 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.j
Date Location User Value Reason
Sep-14-2020 08:43:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Line/
MH N
umber
:10
Medic
al Hist
ory Te
rm:HISTORY OF SPI
NAL MENINGITI
S-NO SYMPTOM
S TODAY
Start
Date:UNK/UNK/2014
Ongoi
ng:NO
End Date:
UNK/UNK/201
8Transcription
Error
Sep-14-2020 08:42:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Line/
MH N
umber
:10
Medic
al Hist
ory Te
rm:HISTORY OF SPI
NAL MENINGITI
S-NO SYMPTOM
S TODAY
Start
Date:UNK/UNK/2014
Ongoi
ng:NO
End Date:
UNK/UNK/199
9updated
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134721
Page 109 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020 16:04:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:10
Medica
l Histor
y Term
:HISTORY OF SPI
NAL MENINGITI
S-NO SYMPTOM
S TODAY
Start D
ate:UNK/UNK/2014
Ongoin
g:YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134722
Page 110 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.j Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:04:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-20-2020
14:00:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Sep-16-2020
17:39:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Rachel
Pugmire
(pfe.rpugmire)Query 1: Answered unknown etiology.
Resolution 2018
Sep-16-2020
12:51:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Spinal
meningitis is
listed from
2014-2018. Please
clarify the
underlying
etiology of this
chronic condition
(if infectious,
what kind of viral
or bacterial
infection?)and
confirm resolution
in 2018
(previously stated
as stable,
ongoing).
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134723
Page 111 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020
16:04:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
HISTORY OF SPINAL M
ENINGITIS-NO SYMPT
OMS TODAYInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-03-2020 16:04:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-16-2020
02:06:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed As per site
confirmation.
Sep-15-2020
01:25:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Closed Response satisfies
query
Sep-14-2020
08:43:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
UNK/UNK/2018Transcription Error
Sep-14-2020
08:43:22
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Query 2: Answered correct as is
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134724
Page 112 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada)
Sep-14-2020
08:42:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For Term
HISTORY OF
SPINAL
MENINGITIS-NO
SYMPTOMS
TODAY End Date
is prior to Start
Date.
Sep-14-2020
08:42:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
UNK/UNK/1999updated
Sep-14-2020
08:41:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Query 1: Answered no ongoing
symptoms. stable
per sub-I.
Sep-14-2020
05:04:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Per
response to
previous queries,
meningitis is
infectious and
ongoing. Please
clarify if disease
was considered
stable by the
investigator as
specified in
inclusion criterion
#3 and if patient
receives any
systemic treatment,
please specify.
Sep-03-2020 ACV0PFEINFP6000 Annjanette Data Entry: Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134725
Page 113 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
16:04:50
(UTC-07:00)
Mountain Time (US
& Canada)Kemp
(pfe.akemp)YES
1.k
Date Location User Value Reason
Sep-08-2020 11:50:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:AUGMENTIN
INTOLERAN
CE
Start Date
:UNK/UNK/20
17
Ongoing: YESTranscription
Error
Sep-04-2020 19:15:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:11
Medical
History
Term:AUGMENTIN I
NTOLERANCE-
OSCILLOPSIA
Start Da
te:UNK/UNK/2017
Ongoing
:YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134726
Page 114 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.k Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:15:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 11:50:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
AUGMENTIN INTOLERA
NCETranscription
Error
Sep-04-2020 19:15:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
AUGMENTIN INTOLERA
NCE-OSCILLOPSIAInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-04-2020 19:15:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-14-2020 05:01:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed new query will be
issued, incorrect
place.
Sep-10-2020 11:23:09
(UTC-07:00)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered infectious
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134727
Page 115 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US
& Canada)
Sep-10-2020 00:22:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Reissued:Opened GPDCLIN: Can
you please clarify
the etiology for
this ongoing
meningitis (
infectious,
autoimmune,
neoplastic?).
Sep-08-2020 11:50:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered ongoing
Sep-07-2020 05:33:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN:
history of
meningitis is
listed as ongoing.
Please provide an
end date or
clarify.
Sep-04-2020 19:15:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:SLEEP AP
NEAInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134728
Page 116 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: Mar/31/201
2
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
SLEEP APNEAInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Mar/31/2012Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.m
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134729
Page 117 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-04-2020 19:16:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:ACTINIC KE
RATOSIS
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134730
Page 118 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.m Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:16:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:16:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
ACTINIC KERATOSISInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-04-2020 19:16:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2010Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-04-2020 19:16:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M 14Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134731
Page 119 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
H Numb
er:
Medical
History
Term:HISTORY OF DI
VERTICULITIS-N
O SYMPTOMS
Start Da
te:UNK/UNK/2010
Ongoing
:YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134732
Page 120 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.n Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
HISTORY OF DIVERTICU
LITIS-NO SYMPTOMSInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-04-2020 19:18:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 15Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134733
Page 121 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
er:
Medical Histor
y Term:LEFT HIP
PAIN
Start Date: UNK/UNK
/2014
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134734
Page 122 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.o Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:18:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:18:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
LEFT HIP PAINInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-04-2020 19:18:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2014Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-04-2020 19:18:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134735
Page 123 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.p
Date Location User Value Reason
Sep-04-2020 19:18:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:LEFT SHOUL
DER PAIN
Start Date: Aug/19/2011
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134736
Page 124 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.p Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:18:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:18:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
LEFT SHOULDER PAINInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-04-2020 19:18:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Aug/19/2011Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-04-2020 19:18:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Sep-04-2020 19:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M 17Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134737
Page 125 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
H Num
ber:
Medical
History
Term:ARTHRITIS OF C
ARPOMETACARP
AL JOINT LEFT T
HUMB
Start D
ate:UNK/UNK/2019
Ongoin
g:YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134738
Page 126 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.q Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-22-2021
03:15:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Feb-19-2021
15:06:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered confirmed
Feb-14-2021
10:07:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Subject
has arthritis and
arthralgia involving
many joints. Please
confirm subject did
not receive any
prohibited systemic
immunosuppressive
therapy (exc #13)
prior to study entry.
Sep-04-2020
19:19:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
ARTHRITIS OF CARPO
METACARPAL JOINT L
EFT THUMBInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134739
Page 127 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.q Start Date:
Date Location User Value Reason
Sep-04-2020 19:19:39
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2019Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-04-2020 19:19:39
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Sep-04-2020 19:20:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:18
Medical
History
Term:BILATERAL IMPA
CTED CERUM OF
EARS-INTERMIT
TENT
Start D
ate:UNK/UNK/2000
Ongoin
g:YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134740
Page 128 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.r Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:20:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:20:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BILATERAL IMPACTED C
ERUM OF EARS-INTERMI
TTENTInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-04-2020 19:20:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2000Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-04-2020 19:20:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-09-2020
10:39:14
(UTC-07:00)ACV0PFEINFP6000 Mikaela
Jones
(pfe mjones)Data Entry:
Line/MH 19Transcription
Error
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134741
Page 129 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US
& Canada)Number:
Medical H
istory Ter
m:Clostridium dif
ficile Infection
Start Date
:Apr/10/2019
Ongoing: NO
End Date:
May/UNK/
2019
Sep-09-2020
09:35:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
Line/MH N
umber:19
Medical Hi
story Term
:Clostridium di
fficile Infectio
n
Start Date: Apr/10/2019
Ongoing: NOTranscription
Error
Sep-09-2020
09:33:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
Line/MH N
umber:19
Medical Hi
story Term
:Clostridium di
fficile Infectio
n
Start Date: Apr/10/2019
Ongoing: YESTranscription
Error
Sep-08-2020 11:51:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
Line/MH Nu
mber:19
Medical Histo
ry Term:Clostridium
difficile
Start Date: Apr/10/201
9Transcription
Error
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134742
Page 130 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: YES
Sep-04-2020
19:20:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:19
Medical History
Term:C-DIFF
Start Date: Apr/10/2
019
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134743
Page 131 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.s Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:20:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-09-2020
12:27:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
2: Clo
sedDiscrepancy has
been closed.
Sep-09-2020
09:33:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dTranscription
Error
Sep-09-2020
09:33:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data
Entry
:
Clostr
idium
diffici
le Infe
ctionTranscription
Error
Sep-08-2020
22:10:49
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
2: Op
enedClarify
CLOSTRIDIUM
DIFFICILE as
follows..Organism
only term. Are
you reporting
TEST? TEST
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134744
Page 132 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
POSITIVE?
INFECTION? If
so, edit.
Otherwise
clarify.Thank you.
Sep-08-2020
14:24:25
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy has
been closed.
Sep-08-2020
11:51:41
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data
Entry
:
Clostr
idium
diffici
leTranscription
Error
Sep-08-2020
11:51:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query
1: An
swere
dclostridium
difficile
Sep-05-2020
10:33:45
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedClarify C-DIFF as
follows...Please
specify the
medical diagnosis
or procedure
being reported. If
reporting C-DIFF
COLITIS or
C-DIFF
INFECTION or
C-DIFF TOXIN
TEST or Other,
please edit as
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134745
Page 133 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
such. Otherwise,
clarify. Thank
you.
Sep-04-2020
19:20:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data
Entry
:
C-DI
FFInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-04-2020 19:20:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Apr/10/2019Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-10-2020 00:16:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Sep-09-2020 10:39:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Mikaela
Jones
(pfe.mjones)Data Entry:
NO
End Date:
May/UNK/2019Transcription
Error
Sep-09-2020 09:35:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-09-2020 09:35:56
(UTC-07:00)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
NOTranscription
Error
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134746
Page 134 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US
& Canada)
Sep-09-2020 04:19:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Please
clarify what C.
Diff ongoing
means or update
term/end date as
applicable.
Sep-04-2020 19:20:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Sep-04-2020 19:21:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:20
Medical H
istory Ter
m:TRIGGER FING
ER LEFT HAND
Start Date
:UNK/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/202
0Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134747
Page 135 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.t Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:21:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:21:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
TRIGGER FINGER LEFT H
ANDInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-04-2020 19:21:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
UNK/UNK/2019Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-04-2020 19:21:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date:
Jan/UNK/2020Initial Entry
1.u
Date Location User Value Reason
Feb-11-2021 08:18:47
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134748
Page 136 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) Line/MH Numb
er:21
Medical Histor
y Term:diverticulos
is
Start Date: UNK/UNK
/2010
Ongoing: YES
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134749
Page 137 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.u Line/MH Number:
Date Location User Value Reason
Feb-11-2021 08:18:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-11-2021 08:18:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
diverticulosisInitial Entry
1.u Start Date:
Date Location User Value Reason
Feb-11-2021 08:18:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
UNK/UNK/2010Initial Entry
1.u Ongoing:
Date Location User Value Reason
Feb-11-2021 08:18:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134750
Page 138 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.v
Date Location User Value Reason
Feb-11-2021 08:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:22
Medical Histo
ry Term:atherosclerosi
s of aorta
Start Date: Apr/23/2019
Ongoing: YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134751
Page 139 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.v Line/MH Number:
Date Location User Value Reason
Feb-11-2021 08:19:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-11-2021 08:19:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
atherosclerosis of aortaInitial Entry
1.v Start Date:
Date Location User Value Reason
Feb-11-2021 08:19:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Apr/23/2019Initial Entry
1.v Ongoing:
Date Location User Value Reason
Feb-11-2021 08:19:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Feb-11-2021 08:19:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 23Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134752
Page 140 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
mber:
Medical Histo
ry Term:coronary arter
y disease
Start Date: Apr/23/2019
Ongoing: YES
1.w Line/MH Number:
Date Location User Value Reason
Feb-11-2021 08:19:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-11-2021 08:19:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
coronary artery diseaseInitial Entry
1.w Start Date:
Date Location User Value Reason
Feb-11-2021 08:19:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Apr/23/2019Initial Entry
1.w Ongoing:
Date Location User Value Reason
Feb-11-2021 08:19:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134753
Page 141 of 205
***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: 10091149 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-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
164.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134754
Page 142 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020 16:05:48
(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
Sep-03-2020 16:05:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.3Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Record Identifi
er::1
Temperature: 97.8
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
97.8Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134755
Page 143 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada)
7.a Unit:
Date Location User Value Reason
Sep-03-2020 16:05:48
(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
Sep-03-2020 16:05:48
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134756
Page 144 of 205
***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: 10091149 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
Sep-03-2020 16:06:30
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 16:06:30
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
249592Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134757
Page 145 of 205
***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: 10091149 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-03-2020 16:15:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 16:15:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 16:15:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 16:15:10
(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-03-2020 16:15:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134758
Page 146 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Sep-03-2020 16:15:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GLPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 16:15:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GLPInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 16:15:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9GLRInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 16:15:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GLRInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 16:16:08
(UTC-07:00)ACV0PFEINFP6000 Annjanette
KempData Entry:
Sample ID: BP9GLSInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134759
Page 147 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US &
Canada)(pfe.akemp)
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 16:16:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9GLSInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020 16:16:33
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BRTSDHInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 16:16:33
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BRTSDHInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020 16:16:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BRTS80Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134760
Page 148 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 16:16:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BRTS80Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134761
Page 149 of 205
***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: 10091149 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-03-2020 16:17:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 16:17:24
(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-03-2020 16:17:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 16:17:24
(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-03-2020 16:17:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134762
Page 150 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Sep-03-2020 16:17:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sample ID: BP9G3NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 16:17:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
BP9G3NInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134763
Page 151 of 205
***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: 10091149 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-03-2020 16:07:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 16:07:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 16:07:18
(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-03-2020 16:07:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
Sep/3/2020 11:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 16:07:18
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134764
Page 152 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-03-2020 16:07:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 16:07:18
(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-03-2020 16:07:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-03-2020 16:07:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134765
Page 153 of 205
***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: 10091149 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
Sep-03-2020 16:07:34
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134766
Page 154 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 14:06:56
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sep/22/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134767
Page 155 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Record Identifi
er::1
Temperature: 97.9
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
97.9Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134768
Page 156 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Unit:
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 14:07:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134769
Page 157 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 14:08:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 14:08:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 14:13:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 14:08:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 14:08:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134770
Page 158 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Sep-22-2020 14:13:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sample ID: BP9G83Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 14:13:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
BP9G83Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134771
Page 159 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sep/22/2020 10:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134772
Page 160 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-22-2020 14:09:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134773
Page 161 of 205
***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: 10091149 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-27-2020 13:15:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Laurie Hawes
(pfe.hawesl01)Query 1: Closed Response
satisfies query
Oct-27-2020 09:57:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered Changed data per
query
Oct-24-2020 10:30:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Prithvee R
(pfe.rp21)Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
Oct-20-2020 19:17:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Krista Marti
(pfe.kmarti)Data Entry:
Oct/20/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134774
Page 162 of 205
***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: 10091149 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-20-2020 19:18:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020 08:36:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Balaji
Prabu R
(pfe.rb01)Query 1: Closed Query raised in
hidden items
Oct-24-2020 07:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Prithvee
R
(pfe.rp21)Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date of
EOT to match the
date the Visit 3.
Oct-20-2020 19:18:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134775
Page 163 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-20-2020 19:22:22
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 19:18:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-20-2020 19:18:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 19:22:22
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sample ID: BR9FMFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 19:22:22
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
BR9FMFInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134776
Page 164 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-20-2020 19:23:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
Sample ID: BKYCY0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 19:23:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe.kmarti)Data Entry:
BKYCY0Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020 19:24:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe kmarti)Data Entry:
Sample ID: BKYCTKTranscription
Error
Oct-20-2020 19:23:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe kmarti)Data Entry:
Sample ID: BKYCTKInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134777
Page 165 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 19:24:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-20-2020 19:24:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 19:24:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Krista
Marti
(pfe kmarti)Data Entry:
BKYCTKTranscription
Error
Oct-20-2020 19:23:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text
or between words.
Please correct by
removing all data
in the field and
re-enter without
adding extra
spaces or using
enter or tab keys.
Oct-20-2020 19:23:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in
length. Please
review and correct
as appropriate.
Oct-20-2020 19:23:26
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Krista
Marti
(pfe kmarti)Data Entry:
BKYCTKInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134778
Page 166 of 205
***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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada)
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134779
Page 167 of 205
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020 09:57:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 09:57:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 09:57:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134780
Page 168 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Form Created
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134781
Page 169 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021
16:37:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-11-2021
14:11:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered Original value is
correct
Feb-02-2021
09:42:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-02-2021
09:41:41
(UTC-07:00)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical SAE
update (01Feb21)
does not report MI
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134782
Page 170 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US
& Canada)(23Apr19) or
Hypertension (?
start) in the SAE
Med History
section; please
update.
Feb-01-2021
15:51:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered updated on SAE
form
Feb-01-2021
15:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 2: Answered updated on sae
form
Jan-27-2021 15:19:00
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical Thank
you; however SAE
report does not
specify if
sigmoidectomy
was performed on
31Dec20 or
01Jan21.
Jan-27-2021 15:18:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened CLINICAL
Subject
undergoing
hemicolectomy
surgery; CV
history would be
relevant for
surgical risk
Jan-25-2021 15:20:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 1: Answered not ongoing or
deemed related to
SAE, not included
per form
instructions
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134783
Page 171 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-25-2021 15:19:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 2: Answered updated SAE form
completed
Jan-25-2021 08:01:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical SAE
report states
subject underwent
sigmoidectomy;
however, no date
is recorded. Please
submit a SAE
safety update with
the date of surgery
for the SAE event.
Jan-25-2021 08:00:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL Past
Med Hx shows an
even Myocardial
Infarction on
23Apr2019;
however, SAE
med history does
not include this.
Please review for
clinical relevance
to surgical
procedure risk, and
update SAE med
Hx if appropriate
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
worsening of diverticulitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)ACV0PFEINFP6000 Dylan
OwenData Entry:
Dec/31/2020 UNK:UNKInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134784
Page 172 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US &
Canada)(pfe.dowen)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-28-2021 18:50:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-26-2021 15:41:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated per
query
Feb-26-2021 15:41:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Annjanette
Kemp
(pfe.akemp)Data Entry:
NO
End Date Time:
Jan/2/2021 UNK:UNKupdated per
query
Feb-25-2021 16:40:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical - Stop
date is 03Jan21;
however, SAE
stop date is
02Jan21. Please
review,
harmonize
reporting, and
update stop date
in the appropriate
location
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
NO
End Date Time:
Jan/3/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134785
Page 173 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-02-2021
09:34:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-01-2021
15:50:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 2: Answered It is known that I
have no record of
a covid test. that is
different than
knowing that no
test was
performed.
Jan-27-2021
15:15:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Reissued:Open
edClinical – Thank
you. If NO
hospital COVID
test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134786
Page 174 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
this trial.
Jan-25-2021
15:19:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Query 2: Answered no covid test
results in records
received
Jan-25-2021
12:16:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 2: Opened Clinical COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021051741] to
document if
COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date
and results.
Jan-25-2021
07:58:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Candidate Clinical COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021051741] to
document if
COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date
and results.
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134787
Page 175 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-25-2021
03:26:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021
10:17:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE worsening
of diverticulitis:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Jan-21-2021
10:17:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Dylan Owen
(pfe.dowen)Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inca
pacity?
NOInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134788
Page 176 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Is this serious event lif
e threatening?
NO
Other medically import
ant serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
underlying illnessInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134789
Page 177 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-21-2021 10:17:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134790
Page 178 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-25-2021 03:26:41
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021051741Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134791
Page 179 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-22-2020 19:34:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Form Created
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134792
Page 180 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-22-2020 19:34:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-22-2020 19:34:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-22-2020 19:34:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is
unknown, enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g.,
Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-22-2020 19:34:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
influenza vaccineInitial Entry
5. Date:
Date Location User Value Reason
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134793
Page 181 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-22-2020 19:34:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Oct/8/2020Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134794
Page 182 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 10:33:04
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Jan/19/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134795
Page 183 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-19-2021
15:03:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-15-2021
19:59:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-15-2021
10:33:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-15-2021
10:33:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madison Ellis
(pfe.mellis)Data Entry:
Participant is willing to ret
urn for Vaccination 3
Participant is:Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134796
Page 184 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eligible per local/nation
al recommendations an
d confirmed to have rec
eived only placebo at V
accination 1/2
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134797
Page 185 of 205
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-19-2021 15:03:33
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-19-2021 15:03:33
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Dylan
Owen
(pfe.dowen)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134798
Page 186 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 10:34:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Feb/15/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134799
Page 187 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
Feb-15-2021 10:34:35
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Feb/15/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134800
Page 188 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
Feb-15-2021 10:34:56
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Feb/15/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-15-2021 10:34:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-15-2021 10:34:56
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134801
Page 189 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 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
Feb-15-2021 10:35:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021 10:35:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-15-2021 10:35:27
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-15-2021 10:35:12
(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.
Feb-15-2021 10:35:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe.mellis)Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134802
Page 190 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Feb-15-2021 10:35:27
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Sample ID: BR6208Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-15-2021 10:35:27
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
BR6208Initial Entry
5.b
Date Location User Value Reason
Feb-15-2021 10:35:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Sample ID: BSJ3YLInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-15-2021 10:35:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
BSJ3YLInitial Entry
5.c
Date Location User Value Reason
Feb-15-2021 10:36:14
(UTC-07:00)ACV0PFEINFP6000 Madison
EllisData Entry:
Sample ID: BSJ4B4Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134803
Page 191 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mountain Time (US &
Canada)(pfe mellis)
5.c Sample ID
Date Location User Value Reason
Feb-15-2021 10:36:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
BSJ4B4Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134804
Page 192 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 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
Feb-15-2021 10:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021 10:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-15-2021 10:37:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-15-2021 10:36:59
(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.
Feb-15-2021 10:36:59
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe.mellis)Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134805
Page 193 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Feb-15-2021 10:37:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Sample ID: BR9FFRInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-15-2021 10:37:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
BR9FFRInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134806
Page 194 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
Feb-15-2021 10:38:16
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Feb/15/2021 09:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134807
Page 195 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134808
Page 196 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-15-2021 10:38:16
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
YESInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134809
Page 197 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 10:33:52
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Mar/8/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134810
Page 198 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 10:37:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 10:37:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 10:38:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 10:37:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 10:37:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe.mellis)Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134811
Page 199 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a
Date Location User Value Reason
Mar-08-2021 10:38:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Sample ID: BR9FJ7Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 10:38:20
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
BR9FJ7Initial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134812
Page 200 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 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
Mar-08-2021 10:37:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
Mar/8/2021 09:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3fa4\Final\Final On: 01-Apr-2021 05:20 (GMT)
FDA-CBER-2021-5683-0134813
Page 201 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic
South
Subject No: 10091149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Madison
Ellis
(pfe mellis)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-08-2021 10:37:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Lo
…[truncated]