125742 S1 M5 CRF c4591001 1006 10061098

Document text

Page 1 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046155
Page 2 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046156
Page 3 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061098]
2.Birth Date: /1954
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
FDA-CBER-2021-5683-0046157
Page 4 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046158
Page 5 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046159
Page 6 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046160
Page 7 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Premarin Allergy (Hives)]
Start Date: UNK/UNK/1989
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Macrodantin Allergy (Hives)]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Muscle Spasms (Whole Body)]
Start Date: Mar/10/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Attention Deficit Hyperactivity Disorder]
Start Date: Feb/1/1989
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046161
Page 8 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma (Moderate)]
Start Date: UNK/UNK/1985
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines with Aura]
Start Date: UNK/UNK/1979
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Sinusitis]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/2017
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastrointestinal Bleed]
Start Date: Nov/27/2017
Ongoing: NO
End Date:
Dec/UNK/2017
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046162
Page 9 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tinnitus Left Ear]
Start Date: Mar/12/2015
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar Disc Degeneration]
Start Date: Aug/14/2014
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mild Anxiety]
Start Date: May/19/2014
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: Sep/13/2013
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046163
Page 10 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Fatigue Syndrome]
Start Date: Aug/14/2012
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: Feb/UNK/2020
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rosacea (mild)]
Start Date: Sep/12/2011
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Complete Hysterectomy]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046164
Page 11 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Partum Hemorrhage]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/1989
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Urethral Sling]
Start Date: UNK/UNK/2018
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Eye Cataracts]
Start Date: Oct/20/2016
Ongoing: NO
End Date:
Feb/16/2017
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046165
Page 12 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Basal Cell Carcinoma (Forehead)]
Start Date: Sep/11/2011
Ongoing: NO
End Date:
Sep/11/2011
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[History of Recurrent Actinic Keratosis]
Start Date: Sep/6/2011
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Restless Leg Syndrome]
Start Date: UNK/UNK/2000
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postural Orthostatic Tachycardia Syndrome]
Start Date: UNK/UNK/1966
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046166
Page 13 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ehlers-Danlos Syndrome]
Start Date: UNK/UNK/1966
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Urinary Tract Infection]
Start Date: UNK/UNK/1974
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Environmental Allergies]
Start Date: UNK/UNK/1969
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046167
Page 14 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [133.2]
3.Unit: LB
4.Height: [65.75]
5.Unit: in
6.Body Mass Index: [21.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046168
Page 15 of 226
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046169
Page 16 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [236124]
3.Randomization Group: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046170
Page 17 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BHV2YP]
5.bSample ID [BHV2YR]
5.cSample ID [BHV2YS]
5.dSample ID [BJ7LYK]
5.eSample ID [BJ7LYL]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046171
Page 18 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BHV2PZ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046172
Page 19 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/24/2020 13:34
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
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046173
Page 20 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046174
Page 21 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046175
Page 22 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046176
Page 23 of 226
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046177
Page 24 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BCT8JS]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046178
Page 25 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 15:51
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
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046179
Page 26 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046180
Page 27 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BCT8F3]
5.bSample ID [BJ7M8J]
5.cSample ID [BJ7MFK]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046181
Page 28 of 226
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046182
Page 29 of 226
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
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 [BS8WTV]
5.bSample ID [BS8WP2]
5.cSample ID [BRBMF5]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046183
Page 30 of 226
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046184
Page 31 of 226
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046185
Page 32 of 226
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046186
Page 33 of 226
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046187
Page 34 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046188
Page 35 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046189
Page 36 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046190
Page 37 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046191
Page 38 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046192
Page 39 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046193
Page 40 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046194
Page 41 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046195
Page 42 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046196
Page 43 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046197
Page 44 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046198
Page 45 of 226
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046199
Page 46 of 226
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046200
Page 47 of 226
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046201
Page 48 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Headache  Aug/24/2020
14:30 NO
End Date Time:
Aug/25/2020 07:0
0
 Repeating
Pages
 2.ADVERSE
EVENT 2  ATRIAL FIBRILLATIO
N INTERMITTENT Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/12/2020 UNK
:UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  URINARY TRACT INF
ECTION Oct/3/2020 U
NK:UNK NO
End Date Time:
Oct/12/2020 UNK
:UNK
 Repeating
Pages
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046202
Page 49 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Headache]
4.Start Date Time: Aug/24/2020 14:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/25/2020 07:00
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).NO
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046203
Page 50 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046204
Page 51 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[ATRIAL FIBRILLATION INTERMITTENT]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046205
Page 52 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly
or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
CONCOMITANT DRUG TREATMENTComments
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046206
Page 53 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[2020405640]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046207
Page 54 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[URINARY TRACT INFECTION]
4.Start Date Time: Oct/3/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046208
Page 55 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:
[BACTERIAL INFECTION]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046209
Page 56 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046210
Page 57 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046211
Page 58 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Medi
cationStart
DateForm Instan
ce
 1.1  VACCINATIO
NS NO  INFLUENZA
VACCINE Oct/2/2
020 Repeating
Pages
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046212
Page 59 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[INFLUENZA VACCINE]
5.Date: Oct/2/2020
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046213
Page 60 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046214
Page 61 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046215
Page 62 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046216
Page 63 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046217
FDA-CBER-2021-5683-0046218
Page 65 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046219
Page 66 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046220
Page 67 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046221
Page 68 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046222
Page 69 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046223
Page 70 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046224
Page 71 of 226
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046225
Page 72 of 226
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046226
Page 73 of 226
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046227
Page 74 of 226
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046228
Page 75 of 226
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046229
Page 76 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046230
Page 77 of 226
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046231
Page 78 of 226
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046232
Page 79 of 226
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046233
Page 80 of 226
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046234
Page 81 of 226
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046235
Page 82 of 226
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046236
Page 83 of 226
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046237
Page 84 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-25-2020 09:05:42 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046238
Page 85 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046239
Page 86 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Aug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046240
Page 87 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Aug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046241
Page 88 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Aug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046242
Page 89 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Aug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046243
Page 90 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Aug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046244
Page 91 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046245
Page 92 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046246
Page 93 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:27:15 (UTC-07:00)
Mountain Time (US & Canada)Ty Henry
(pfe.thenry)Not Applicable
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046247
Page 94 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Oct-21-2020 09:35:27 (UTC-07:00)
Mountain Time (US & Canada)Lindsey Bevan
(pfe.lbevan)CIPROFLOXACIN
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046248
Page 95 of 226
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Ashley Bragg  N/A Mar-09-2021 17:10:11 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James
Peterson Approved Mar-08-2021 15:51:47 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Bradley
Young N/A Feb-26-2021 08:18:39 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James
Peterson Approved Jan-26-2021 21:29:37 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046249
Page 96 of 226
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
Lindsey
Bevan N/A Jan-25-2021 13:38:04 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James
Peterson Approved Oct-30-2020 14:11:54 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, 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.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046250
Page 97 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020
09:04:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020
09:04:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046251
Page 98 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020
09:04:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
OBTAINED
Date Written Consent Obt
ained
Aug/24/2020Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046252
Page 99 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020
09:04:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10061098Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
09:03:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
09:04:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020
09:04:50
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
FDA-CBER-2021-5683-0046253
Page 100 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
09:04:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
WHITEInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046254
Page 101 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020
09:05:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046255
Page 102 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020
09:06:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
09:06:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
09:06:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046256
Page 103 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020
09:10:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Premarin All
ergy (Hives)
Start Date: UNK/UNK/1
989
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:10:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:10:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Premarin Allergy (Hives)Initial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046257
Page 104 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-25-2020
09:10:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1989Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
09:10:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-25-2020
09:11:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:Macrodantin
Allergy (Hive
s)
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046258
Page 105 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:11:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:11:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Macrodantin Allergy (Hive
s)Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020
09:11:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020
09:11:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046259
Page 106 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c
Date Location User Value Reason
Aug-25-2020
09:12:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Recurrent Muscl
e Spasms (Whol
e Body)
Start Dat
e:Mar/10/2017
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046260
Page 107 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:12:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-30-2020
07:40:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Oct-29-2020
12:53:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered No diagnosis
assigned by any
provider
Oct-27-2020
01:39:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Reissued:Ope
nedGPDCLIN: please
clarify if there is a
known
diagnosis/underlying
condition that can be
added to medical
history. thank you
Oct-26-2020
17:33:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Confirmed "whole
body" in source
documentation.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046261
Page 108 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-24-2020
22:03:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Samuel
Dychter
(pfe.dychts)Query 1: Opened GPD Clin: Please
clarify if the subject
has a diagnosis that
relates to the whole
body muscle
spasms.
Aug-25-2020
09:12:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Recurrent Muscle Spas
ms (Whole Body)Initial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020
09:12:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Mar/10/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020
09:12:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-25-2020
09:12:57ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH 4Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046262
Page 109 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00)
Mountain Time (US
& Canada)Number:
Medical
History T
erm:Attention Defici
t Hyperactivity
Disorder
Start Dat
e:Feb/1/1989
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046263
Page 110 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:12:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020
12:56:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Oct-23-2020
13:42:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Changed data
per query
Oct-23-2020
09:37:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL -
SAE Med Hx
reports subject
has postural
orthostatic
tachycardia
syndrome (no
date of onset).
Please review
for clinical
relevance to
safety, and add
this Med hx to
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046264
Page 111 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
CRF if
appropriate
(with onset date
if available)
Aug-25-2020
09:12:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Attention Deficit Hypera
ctivity DisorderInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020
09:12:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Feb/1/1989Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020
09:12:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020
09:13:23
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046265
Page 112 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada) Medical Histo
ry Term:Asthma (M
oderate)
Start Date: UNK/UNK/
1985
Ongoing: YES
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046266
Page 113 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:13:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:13:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Asthma (Moderate)Initial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020
09:13:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1985Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020
09:13:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046267
Page 114 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f
Date Location User Value Reason
Aug-25-2020
09:14:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Migraines w
ith Aura
Start Date: UNK/UNK/
1979
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046268
Page 115 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:14:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:14:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Migraines with AuraInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020
09:14:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1979Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020
09:14:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046269
Page 116 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g
Date Location User Value Reason
Aug-25-2020
09:15:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Recurrent Si
nusitis
Start Date: UNK/UNK/
1980
Ongoing: NO
End Date:
UNK/UN
K/2017Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046270
Page 117 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:15:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:15:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Recurrent SinusitisInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020
09:15:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020
09:15:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046271
Page 118 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.h
Date Location User Value Reason
Aug-25-2020
09:16:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Gastrointesti
nal Bleed
Start Date: Nov/27/2017
Ongoing: NO
End Date:
Dec/UNK
/2017Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046272
Page 119 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:16:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:16:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Gastrointestinal BleedInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020
09:16:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Nov/27/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020
09:16:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NO
End Date:
Dec/UNK/2017Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046273
Page 120 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.i
Date Location User Value Reason
Aug-25-2020
09:17:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histo
ry Term:Tinnitus L
eft Ear
Start Date: Mar/12/20
15
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046274
Page 121 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:17:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:17:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Tinnitus Left EarInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020
09:17:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Mar/12/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020
09:17:14
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046275
Page 122 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
1.j
Date Location User Value Reason
Aug-25-2020
09:18:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Lumbar Disc
Degeneration
Start Date: Aug/14/2014
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046276
Page 123 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.j Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:18:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:18:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Lumbar Disc DegenerationInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-25-2020
09:18:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/14/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-25-2020
09:18:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046277
Page 124 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.k
Date Location User Value Reason
Aug-25-2020
09:19:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Mild Anx
iety
Start Date: May/19/2
014
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046278
Page 125 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.k Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:19:19
(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
Aug-25-2020
09:19:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Mild AnxietyInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-25-2020
09:19:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
May/19/2014Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-25-2020
09:19:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046279
Page 126 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.l
Date Location User Value Reason
Aug-25-2020
09:20:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:Insomnia
Start Date: Sep/13/2
013
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046280
Page 127 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.l Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:20:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:20:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
InsomniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-25-2020
09:20:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/13/2013Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-25-2020
09:20:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046281
Page 128 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.m
Date Location User Value Reason
Aug-25-2020
09:20:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical His
tory Term:Chronic Fatig
ue Syndrome
Start Date: Aug/14/2012
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046282
Page 129 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.m Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:20:45
(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
Aug-25-2020
09:20:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Chronic Fatigue SyndromeInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-25-2020
09:20:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/14/2012Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-25-2020
09:20:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046283
Page 130 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.n
Date Location User Value Reason
Aug-25-2020
09:21:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Osteoporo
sis
Start Date: Feb/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046284
Page 131 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.n Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:21:09
(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
Aug-25-2020
09:21:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
OsteoporosisInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-25-2020
09:21:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Feb/UNK/2020Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-25-2020
09:21:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046285
Page 132 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.o
Date Location User Value Reason
Aug-25-2020
09:22:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:15
Medical Histor
y Term:Rosacea (
mild)
Start Date: Sep/12/20
11
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046286
Page 133 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.o Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:22:19
(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
Aug-25-2020
09:22:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Rosacea (mild)Initial Entry
1.o Start Date:
Date Location User Value Reason
Aug-25-2020
09:22:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/12/2011Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-25-2020
09:22:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046287
Page 134 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.p
Date Location User Value Reason
Aug-27-2020
14:00:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH
Number:16
Medical Hi
story Term
:Complete Hy
sterectomy
Start Date: UNK/UNK/1
989
Ongoing: NO
End Date:
UNK/UN
K/1989Transcription
Error
Aug-25-2020
09:22:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:16
Medical His
tory Term:Complete H
ysterectomy
Start Date: UNK/UNK/
1989
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046288
Page 135 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.p Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:22:45
(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
Aug-25-2020
09:22:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Complete HysterectomyInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-25-2020
09:22:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1989Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-01-2020
18:05:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Hao Hu
(pfe.huh17)Query 1: Closed Response satisfies
query
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046289
Page 136 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-27-2020
14:00:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Aug-27-2020
14:00:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
UNK/UNK/1989Transcription Error
Aug-26-2020
19:09:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Hao Hu
(pfe.huh17)Query 1: Opened ClinQuery:
HYSTERECTOMY:
As this is a
procedure, please
provide stop date.
Aug-25-2020
09:22:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-27-2020
14:00:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH
Number:17
Medical Hi
story Term
:Post Partum
Hemorrhage
Start Date: UNK/UNK/1
989Transcription
Error
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046290
Page 137 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UN
K/1989
Aug-25-2020
09:23:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:17
Medical Hi
story Term:Post Partum
Hemorrhage
Start Date: UNK/UNK/
1989
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046291
Page 138 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.q Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:23:11
(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
Aug-27-2020
14:05:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
Gong
(pfe.gongq)Query 1: Closed Response
satisfies query
Aug-27-2020
14:01:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Changed data per
query
Aug-26-2020
10:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
Gong
(pfe.gongq)Query 1: Opened GPDClin: Please
confirm if this is
a past condition
(resolved after
hysterectomy
1989). If yes,
please add End
Date.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046292
Page 139 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
09:23:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Post Partum HemorrhageInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-25-2020
09:23:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1989Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-27-2020
14:00:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
End Date:
UNK/UNK/1989Transcription
Error
Aug-25-2020
09:23:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
1.r
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046293
Page 140 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-25-2020
09:23:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18
Medical Histor
y Term:Postmenop
ausal
Start Date: UNK/UN
K/1989
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046294
Page 141 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.r Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:23:31
(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
Aug-25-2020
09:23:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
PostmenopausalInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-25-2020
09:23:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/1989Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-25-2020
09:23:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046295
Page 142 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.s
Date Location User Value Reason
Aug-25-2020
09:23:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:19
Medical Histor
y Term:Urethral Sl
ing
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046296
Page 143 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.s Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:23:57
(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 Value Reason
Aug-25-2020
09:23:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Urethral SlingInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-25-2020
09:23:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
UNK/UNK/2018Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-25-2020
09:23:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046297
Page 144 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.t
Date Location User Value Reason
Aug-25-2020
09:24:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Hist
ory Term:Bilateral Eye
Cataracts
Start Date: Oct/20/2016
Ongoing: NO
End Date:
Feb/16/20
17Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046298
Page 145 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.t Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:24:42
(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
Aug-25-2020
09:24:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Bilateral Eye CataractsInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-25-2020
09:24:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Oct/20/2016Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-25-2020
09:24:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NO
End Date:
Feb/16/2017Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046299
Page 146 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.u
Date Location User Value Reason
Aug-25-2020
09:25:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:21
Medical H
istory Ter
m:Basal Cell Carc
inoma (Forehea
d)
Start Date
:Sep/11/2011
Ongoing: NO
End Date:
Sep/11/2011Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046300
Page 147 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.u Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:25:28
(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
Aug-25-2020
09:25:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Basal Cell Carcinoma (For
ehead)Initial Entry
1.u Start Date:
Date Location User Value Reason
Aug-25-2020
09:25:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/11/2011Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-25-2020
09:25:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NO
End Date:
Sep/11/2011Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046301
Page 148 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.v
Date Location User Value Reason
Aug-25-2020
09:26:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:22
Medical
History T
erm:History of Recu
rrent Actinic Ke
ratosis
Start Date
:Sep/6/2011
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046302
Page 149 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.v Line/MH Number:
Date Location User Value Reason
Aug-25-2020
09:26:13
(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
Aug-25-2020
09:26:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
History of Recurrent Actini
c KeratosisInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-25-2020
09:26:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/6/2011Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-25-2020
09:26:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046303
Page 150 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.w
Date Location User Value Reason
Sep-16-2020 08:28:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:23
Medical Hist
ory Term:Restless Leg
Syndrome
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046304
Page 151 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.w Line/MH Number:
Date Location User Value Reason
Sep-16-2020 08:28:16
(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
Sep-16-2020
08:28:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Restless Leg SyndromeInitial Entry
1.w Start Date:
Date Location User Value Reason
Sep-16-2020
08:28:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
UNK/UNK/2000Initial Entry
1.w Ongoing:
Date Location User Value Reason
Sep-16-2020
08:28:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046305
Page 152 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.x
Date Location User Value Reason
Oct-23-2020 13:42:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:24
Medical
History T
erm:Postural Orthost
atic Tachycardia
Syndrome
Start Dat
e:UNK/UNK/196
6
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046306
Page 153 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.x Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:42:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020
13:42:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Postural Orthostatic Tachyc
ardia SyndromeInitial Entry
1.x Start Date:
Date Location User Value Reason
Oct-23-2020
13:42:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1966Initial Entry
1.x Ongoing:
Date Location User Value Reason
Oct-23-2020
13:42:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046307
Page 154 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.y
Date Location User Value Reason
Oct-27-2020
16:24:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH N
umber:25
Medical Hi
story Term:Ehlers-Danl
os Syndrom
e
Start Date: UNK/UNK/
1966
Ongoing: YESChanged
Information
Oct-26-2020
17:32:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:25
Medical Histo
ry Term:Ehlers-Da
nlos
Start Date: UNK/UN
K/1966
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046308
Page 155 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.y Line/MH Number:
Date Location User Value Reason
Oct-26-2020 17:32:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Oct-27-2020
22:20:05
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy
has been
closed.
Oct-27-2020
16:24:16
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged
Information
Oct-27-2020
16:24:16
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data
Entry
:
Ehlers
-Danl
os Sy
ndro
meChanged
Information
Oct-27-2020
01:24:28
(UTC-07:00)
MountainACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedClarify
EHLERS-
DANLOS as
follows...The
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046309
Page 156 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US &
Canada)term appears
incomplete. If
reporting
EHLERS-
DANLOS
SYNDROME,
update the
verbatim term
as such.
Otherwise
clarify and
update the
term as
appropriate.
Thank you.
Oct-26-2020
17:32:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data
Entry
:
Ehlers
-Danl
osInitial Entry
1.y Start Date:
Date Location User Value Reason
Oct-26-2020
17:32:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1966Initial Entry
1.y Ongoing:
Date Location User Value Reason
Oct-26-2020
17:32:09ACV0PFEINFP6000  Lindsey
BevanData Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046310
Page 157 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00)
Mountain Time (US
& Canada)(pfe.lbevan)
1.z
Date Location User Value Reason
Oct-26-2020 17:32:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:26
Medical Hi
story Term
:Recurrent Urin
ary Tract Infect
ion
Start Date: UNK/UNK/19
74
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046311
Page 158 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.z Line/MH Number:
Date Location User Value Reason
Oct-26-2020 17:32:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020
17:32:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Recurrent Urinary Tract Inf
ectionInitial Entry
1.z Start Date:
Date Location User Value Reason
Oct-26-2020
17:32:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1974Initial Entry
1.z Ongoing:
Date Location User Value Reason
Oct-26-2020
17:32:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046312
Page 159 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.aa
Date Location User Value Reason
Oct-26-2020 17:32:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:27
Medical Hist
ory Term:Environment
al Allergies
Start Date: UNK/UNK/1
969
Ongoing: YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046313
Page 160 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.aa Line/MH Number:
Date Location User Value Reason
Oct-26-2020 17:32:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020
17:32:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Environmental AllergiesInitial Entry
1.aa Start Date:
Date Location User Value Reason
Oct-26-2020
17:32:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/1969Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Oct-26-2020
17:32:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046314
Page 161 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
133.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
65.75Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046315
Page 162 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
5. Unit:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.7Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Record Identif
ier::1
Temperature: 98.3
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046316
Page 163 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
09:26:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046317
Page 164 of 226
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046318
Page 165 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sponsor-Define
d Identifier:Not App
licable
Test:: Not App
licable
Result:: Not App
licable
Not Done:: Not App
licableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
6.a Test:
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046319
Page 166 of 226
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-25-2020
09:27:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046320
Page 167 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020
09:27:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
09:27:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
236124Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046321
Page 168 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
09:28:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
09:28:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
08:37:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-26-2020
01:03:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046322
Page 169 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate.
Aug-25-2020
09:28:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-25-2020
09:28:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
08:37:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2YPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
08:37:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2YPInitial Entry
5.b
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046323
Page 170 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-26-2020
08:37:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2YRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020
08:37:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2YRInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
08:37:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2YSInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020
08:37:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2YSInitial Entry
5.d
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046324
Page 171 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-26-2020
08:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7LYKInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020
08:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7LYKInitial Entry
5.e
Date Location User Value Reason
Aug-26-2020
08:37:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7LYLInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020
08:37:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7LYLInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046325
Page 172 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
09:28:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
09:28:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
08:38:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-26-2020
01:07:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046326
Page 173 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate.
Aug-25-2020
09:28:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-25-2020
09:28:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
08:38:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2PZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
08:38:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2PZInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046327
Page 174 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Aug/24/2020 13:34Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046328
Page 175 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046329
Page 176 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-25-2020
09:28:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046330
Page 177 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020
09:29:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046331
Page 178 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
08:19:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046332
Page 179 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Record Identi
fier::1
Temperature: 98.4
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046333
Page 180 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
08:19:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046334
Page 181 of 226
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020
08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046335
Page 182 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020
08:19:51
(UTC-07:00)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Choriogonadotropin Beta_
PX113Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046336
Page 183 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)
6.a Not Done:
Date Location User Value Reason
Sep-16-2020
08:19:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOT DONEInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046337
Page 184 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 08:19:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 08:19:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
08:20:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
08:19:59
(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.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046338
Page 185 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020
08:19:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
08:20:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Sample ID: BCT8JSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
08:20:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
BCT8JSInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046339
Page 186 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-16-2020
08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Sep/15/2020 15:51Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046340
Page 187 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020
08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020 08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046341
Page 188 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020
08:20:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
YESInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046342
Page 189 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
14:18:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Oct/19/2020Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046343
Page 190 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 14:17:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 14:17:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
14:18:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
14:17:51
(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.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046344
Page 191 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-19-2020
14:17:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
14:18:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BCT8F3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
14:18:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BCT8F3Initial Entry
5.b
Date Location User Value Reason
Oct-19-2020
14:18:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BJ7M8JInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046345
Page 192 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
14:18:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BJ7M8JInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
14:18:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BJ7MFKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
14:18:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BJ7MFKInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046346
Page 193 of 226
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021
17:10:11
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ashley
Bragg
(pfe.abragg)Data Entry:
Mar/9/2021Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046347
Page 194 of 226
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021
17:10:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021
17:10:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021
10:54:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-10-2021
04:40:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046348
Page 195 of 226
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate.
Mar-09-2021
17:10:21
(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-09-2021
17:10:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ashley
Bragg
(pfe.abragg)Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021
10:54:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
Sample ID: BS8WTVInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021
10:54:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
BS8WTVInitial Entry
5.b
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046349
Page 196 of 226
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Mar-11-2021
10:54:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
Sample ID: BS8WP2Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-11-2021
10:54:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
BS8WP2Initial Entry
5.c
Date Location User Value Reason
Mar-11-2021
11:08:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
Sample ID: BRBMF5Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-11-2021
11:08:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Kenadie
Hamblin
(pfe.khamblin)Data Entry:
BRBMF5Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046350
Page 197 of 226
***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020
14:18:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 14:18:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
14:18:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046351
Page 198 of 226
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-16-2020 08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
Wilcox
(pfe.ewilcox)Form Created
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046352
Page 199 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madeline Kay
Maldonado
(pfe.mmaldonado)Form Created
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046353
Page 200 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Madeline Kay
Maldonado
(pfe.mmaldonado)Form Created
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046354
Page 201 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-16-2020 08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-16-2020 08:21:15
(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
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
Aug/24/2020 14:30Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046355
Page 202 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NO
End Date Time:
Aug/25/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)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
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
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
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046356
Page 203 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046357
Page 204 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-16-2020
08:21:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Emily
Wilcox
(pfe.ewilcox)Data Entry:
NOInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046358
Page 205 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
ATRIAL FIBRILLATI
ON INTERMITTENTInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020
16:06:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
Oct/6/2020 UNK:UN
KTranscription
Error
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046359
Page 206 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
Oct/12/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020
16:06:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NO
End Date Time:
Oct/12/2020 UNK:
UNKTranscription
Error
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)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).
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046360
Page 207 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-29-2020
15:03:30
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe.frantu)Query 3: Closed Response satisfies
query
Oct-29-2020
12:41:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-29-2020
12:41:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prolo
ng hospitalization?
NO
Did this serious ev
ent result in persist
ent or significant di
sability/incapacity?
NOTranscription Error
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046361
Page 208 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Is this serious even
t life threatening?
NO
Other medically im
portant serious eve
nt
YES
Oct-29-2020
12:18:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R
(pfe.rb01)Query 3: Opened Only the
seriousness criteria
"Other medically
important serious
event" is answered,
all other serious
criterias are left
blank. Please
answer all
seriousness criteria
questions with
"Yes" or "No"
response. Thank
you.
Oct-20-2020
04:14:37
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020
00:23:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Closed Response satisfies
query
Oct-19-2020 ACV0PFEINFP6000  Madeline Kay Query 2: Answered Query is
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046362
Page 209 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
16:07:13
(UTC-07:00)
Mountain Time
(US & Canada)Maldonado
(pfe.mmaldonado)ambiguous
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness criteria
is missing. Please
review and update
as appropriate.
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE ATRIAL
FIBRILLATION
INTERMITTENT:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
YES
Other medically im
portant serious eve
nt
YESInitial Entry
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
Oct-19-2020
16:06:24
(UTC-07:00)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046363
Page 210 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mountain Time (US
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-22-2020
02:11:47
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Closed comment added.
Oct-21-2020
09:35:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query 1: Answered Changed data
per query
Oct-20-2020
11:24:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN:
Please specify
the concomitant
drug that led to
this AE. Please
consider adding
the name of the
drug here or as a
comment.
Oct-19-2020
16:08:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
CONCOMITANT
DRUG TREATME
NTTranscription
Error
Oct-19-2020 ACV0PFEINFP6000  Madeline Kay Data Entry: Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046364
Page 211 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)Maldonado
(pfe.mmaldonado)NOT RELATED
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 ACV0PFEINFP6000  auto query Query 1: Closed Close Auto Query
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046365
Page 212 of 226
***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, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
16:06:55
(UTC-07:00)
Mountain Time
(US & Canada)(autoquery)
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE ATRIAL
FIBRILLATION
INTERMITTENT:
Response to "What
was the outcome
of this adverse
event?" is 3 but
End Date/Time is
missing.
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020
16:06:24
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-20-2020
04:14:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020405640Initial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046366
Page 213 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
URINARY TRACT IN
FECTIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
Oct/3/2020 UNK:UNKInitial Entry
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046367
Page 214 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NO
End Date Time:
Oct/12/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020
16:09:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
3Initial 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
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOInitial Entry
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.
090177e196ae3d22\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0046368
Page 215 of 226
***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, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family
Clinic
Subject No: 10061098 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Madeline Kay
Maldonado
(pfe.mmaldonado)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020
16:09:31
(UTC-07:
…[truncated]