125742 S1 M5 CRF c4591001 1006 10061094

Document text

Page 1 of 249
***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: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045906
Page 2 of 249
***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: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045907
Page 3 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061094]
2.Birth Date: /1985
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:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045908
Page 4 of 249
***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: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045909
Page 5 of 249
***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: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045910
Page 6 of 249
***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: 10061094 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: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045911
Page 7 of 249
***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: 10061094 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:[MIGRAINES]
Start Date: UNK/UNK/2003
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MUSCLE SPASMS (BACK AND SHOULDERS)]
Start Date: UNK/UNK/2003
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MILD ASTHMA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/1988
Ongoing: YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045912
Page 8 of 249
***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: 10061094 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:[OPSTURAL ORTHOSTATIC TACHYCHARDIA SYNDROME]
Start Date: UNK/UNK/1986
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[EHLRS DAULOS SYNDROME]
Start Date: UNK/UNK/1986
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST TRAUMATIC STRESS DISORDER]
Start Date: UNK/UNK/1980
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIFFUSE SPASTIC ESOPHAGUS]
Start Date: UNK/UNK/2015
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ORAL COLD SORES]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045913
Page 9 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ATTENTION DEFICIT DISORDER]
Start Date: UNK/UNK/1998
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TEMPORPMANDIBULAR JOINT DYSFUNCTION]
Start Date: UNK/UNK/2003
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NISSEN FUNDIPLICATION]
Start Date: UNK/UNK/2009
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/1986
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEVIATED SEPTUM]
Start Date: UNK/UNK/1987
Ongoing: NO
End Date:
UNK/UNK/2004
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045914
Page 10 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEART MURMUR]
Start Date: UNK/UNK/2019
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEVIATED SEPTUM REPAIR]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACNE (FACIAL)]
Start Date: UNK/UNK/1998
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[AMOXICILLIN ALLERGY]
Start Date: UNK/UNK/1990
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IODINATED CONTRAST MEDIA ALLERGY]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045915
Page 11 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PENICILLIN G ALLERGY]
Start Date: UNK/UNK/1990
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RECURRENT SINUSITIS]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045916
Page 12 of 249
***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: 10061094 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: [137.6]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [20.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045917
Page 13 of 249
***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: 10061094 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: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045918
Page 14 of 249
***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: 10061094 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: [61617]
3.Randomization Group: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045919
Page 15 of 249
***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: 10061094 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 [BHV2Y9]
5.bSample ID [BHV2YB]
5.cSample ID [BHV2YC]
5.dSample ID [BJ7LY9]
5.eSample ID [BJ7LYB]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045920
Page 16 of 249
***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: 10061094 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 [BHV2PV]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045921
Page 17 of 249
***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: 10061094 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 09:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045922
Page 18 of 249
***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: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045923
Page 19 of 249
***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: 10061094 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/18/2020
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045924
Page 20 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045925
Page 21 of 249
***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: 10061094 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/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045926
Page 22 of 249
***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: 10061094 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SAMPLE CAPTURED IN COVID ILLNESS VISIT A]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BH2422]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045927
Page 23 of 249
***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: 10061094 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/18/2020 13:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045928
Page 24 of 249
***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: 10061094 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/16/2020
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045929
Page 25 of 249
***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: 10061094 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/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BCT8DR]
5.bSample ID [BJ7M85]
5.cSample ID [BJ7MF6]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045930
Page 26 of 249
***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: 10061094 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/12/2021
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045931
Page 27 of 249
***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: 10061094 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/12/2021
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 [BRBMG0]
5.bSample ID [BS8WM8]
5.cSample ID [BS8WPN]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045932
Page 28 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045933
Page 29 of 249
***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: 10061094 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 [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045934
Page 30 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045935
Page 31 of 249
***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: 10061094 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 [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045936
Page 32 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10061094 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/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045937
Page 33 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/18/2020
2.Date of First Symptom Started: Sep/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045938
Page 34 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [NASAL CONGESTION]
5.bSymptoms - Other Text: [NASAL DISCHARGE DISCOLORATION]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045939
Page 35 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045940
Page 36 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045941
Page 37 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10061094 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SWAB PFE COLLECTED AT VISIT 2]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045942
Page 38 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10061094 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/18/2020
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 [BH2422]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045943
Page 39 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045944
FDA-CBER-2021-5683-0045945
Page 41 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045946
Page 42 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[UPPER RESPIRATORY TRACT INFECTION]
Date of Diagnosis:
Sep/18/2020
3.Toxicity Grade: 2
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045947
FDA-CBER-2021-5683-0045948
Page 44 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045949
Page 45 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045950
Page 46 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045951
Page 47 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045952
Page 48 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045953
FDA-CBER-2021-5683-0045954
Page 50 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045955
FDA-CBER-2021-5683-0045956
Page 52 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045957
FDA-CBER-2021-5683-0045958
Page 54 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: OXYGENATION PARAMETERS
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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045959
Page 55 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045960
Page 56 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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.Start Date: //
6.Ongoing?
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045961
FDA-CBER-2021-5683-0045962
Page 58 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045963
Page 59 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045964
Page 60 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10061094 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/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BH2442]
5.bSample ID [BSJPKD]
5.cSample ID [BJ7MG7]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045965
Page 61 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045966
Page 62 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045967
Page 63 of 249
***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: 10061094 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/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045968
Page 64 of 249
***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: 10061094 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: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045969
Page 65 of 249
***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: 10061094 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:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045970
Page 66 of 249
***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: 10061094 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 [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045971
Page 67 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  Upper Respiratory T
ract Infection Sep/10/2020 U
NK:UNK NO
End Date Time:
Sep/15/2020 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  INJECTION SITE P
AIN Sep/19/2020 18
:00 NO
End Date Time:
Sep/20/2020 18:00
 Repeating
Pages
 3. ADVERSE
EVENT 3  FEVER  Sep/19/2020 18
:00 NO
End Date Time:
Sep/20/2020 18:00
 Repeating
Pages
 4. ADVERSE
EVENT 4  GENERALIZED A
CHES Sep/19/2020 18
:00 NO
End Date Time:
Sep/20/2020 18:00
 Repeating
Pages
 5. ADVERSE
EVENT 5  Exposure During Pre
gnancy Nov/15/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045972
Page 68 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Upper Respiratory Tract Infection ]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[URI VIRAL ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045973
Page 69 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045974
Page 70 of 249
***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: 10061094 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)[INJECTION SITE PAIN]
4.Start Date Time: Sep/19/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 18:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045975
Page 71 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045976
Page 72 of 249
***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: 10061094 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)[FEVER]
4.Start Date Time: Sep/19/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 18:00
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
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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045977
Page 73 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045978
Page 74 of 249
***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: 10061094 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[GENERALIZED ACHES]
4.Start Date Time: Sep/19/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 18:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045979
Page 75 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045980
Page 76 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Exposure During Pregnancy]
4.Start Date Time: Nov/15/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[condom failure]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045981
Page 77 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045982
Page 78 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045983
Page 79 of 249
***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: 10061094 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[ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045984
Page 80 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045985
Page 81 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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.Date: //
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045986
Page 82 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045987
Page 83 of 249
***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: 10061094 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?
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045988
FDA-CBER-2021-5683-0045989
Page 85 of 249
***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: 10061094 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?
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045990
FDA-CBER-2021-5683-0045991
Page 87 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045992
Page 88 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045993
Page 89 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045994
Page 90 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045995
Page 91 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10061094 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?
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045996
Page 92 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045997
Page 93 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045998
Page 94 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0045999
Page 95 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046000
Page 96 of 249
***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: 10061094 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 [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046001
Page 97 of 249
***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: 10061094 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 [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046002
Page 98 of 249
***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: 10061094 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 Feb/2/2021
2.Erroneous Visit
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046003
Page 99 of 249
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046004
Page 100 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046005
Page 101 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046006
Page 102 of 249
***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: 10061094 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: [ ]
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046007
Page 103 of 249
***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: 10061094 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/16/2020
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046008
Page 104 of 249
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046009
Page 105 of 249
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046010
Page 106 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-25-2020 14:47:45 (UTC-07:00) Mountain
Time (US & Canada)Maddie Grote
(pfe.mgrote)Not Applicable
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046011
Page 107 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046012
Page 108 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046013
Page 109 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046014
Page 110 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046015
Page 111 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046016
Page 112 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046017
Page 113 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046018
Page 114 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046019
Page 115 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046020
Page 116 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Oct-21-2020 15:33:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046021
Page 117 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Dec-03-2020 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046022
Page 118 of 249
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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
Bradley Young  N/A Mar-12-2021 11:07:51 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson  Approved Mar-08-2021 15:49:52 (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.
Lindsey Bevan  N/A Feb-05-2021 14:01:58 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson  Approved Jan-22-2021 19:10:36 (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.
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046023
Page 119 of 249
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lindsey Bevan  N/A Dec-03-2020 13:41:52 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson  Approved Dec-01-2020 17:44:54 (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.
Bradley Young  N/A Dec-01-2020 17:39:48 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson  Approved Oct-29-2020 14:11:08 (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.
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046024
Page 120 of 249
***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: 10061094 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 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)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 14:46:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046025
Page 121 of 249
***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: 10061094 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 14:47:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046026
Page 122 of 249
***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: 10061094 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 14:46:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10061094Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 14:46:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 14:47:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 14:47:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020 14:47:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
WHITEInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
FDA-CBER-2021-5683-0046027
Page 123 of 249
***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: 10061094 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-30-2020 04:26:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Per site
confirmation
Sep-29-2020 04:18:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Candidate Added to DM Ops
tracker. Kindly
review the Ops
tracker and take
appropriate action.
Sep-28-2020 11:47:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Deemed not related
to COVID per
investigator
Sep-28-2020 11:19:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sonali shah
(pfe.shahs132)Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
31AUG2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Aug-25-2020 14:47:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie Grote
(pfe mgrote)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046028
Page 124 of 249
***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: 10061094 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 14:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 14:48:01
(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 14:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046029
Page 125 of 249
***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: 10061094 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 14:48:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:MIGRAINES
Start Date: UNK/UNK/2
003
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:48:38
(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 14:48:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
MIGRAINESInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 14:48:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2003Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 14:48:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046030
Page 126 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b
Date Location User Value Reason
Aug-25-2020 14:49:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:MUSCLE SPASMS (
BACK AND SHOUL
DERS)
Start Date
:UNK/UNK/2003
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046031
Page 127 of 249
***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: 10061094 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 14:49:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 02:47:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lingyan Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Sep-08-2020 15:03:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered Related to MedHx
Item #1
Sep-04-2020 00:02:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Rajashekhar
Reddy
(pfe.reddyr51)Query 1: Opened ClinQuery: Muscle
Spasms: Please can
you confirm if a
diagnosis is
available for this
medhx?
Sep-03-2020 18:50:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lingyan Zuo
(pfe.zuol02)Query 1: Candidate ClinQuery: Muscle
Spasms: Please can
you confirm if a
diagnosis is
available for this
medhx?
Aug-25-2020 14:49:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie Grote
(pfe.mgrote)Data Entry:
MUSCLE SPASMS (BACK AN
D SHOULDERS)Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 14:49:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046032
Page 128 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-25-2020 14:49:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-25-2020 14:49:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:MILD ASTH
MA
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046033
Page 129 of 249
***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: 10061094 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 14:49:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:49:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
MILD ASTHMAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 14:49:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 14:49:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-25-2020 14:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:SEASONAL AL
LERGIES
Start Date: UNK/UNK/1988
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046034
Page 130 of 249
***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: 10061094 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 14:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
SEASONAL ALLERGIESInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 14:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1988Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 14:49:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020 14:50:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History
Term:OPSTURAL ORTHOS
TATIC TACHYCHAR
DIA SYNDROME
Start Dat
e:UNK/UNK/1986
Ongoing
:YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046035
Page 131 of 249
***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: 10061094 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 14:50:50
(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 14:50:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
OPSTURAL ORTHOSTATIC TA
CHYCHARDIA SYNDROMEInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 14:50:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1986Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 14:50:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-25-2020 14:52:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:EHLRS DAULOS
SYNDROME
Start Date: UNK/UNK/1986
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046036
Page 132 of 249
***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: 10061094 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 14:52:02
(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 14:52:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
EHLRS DAULOS SYNDROMEInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 14:52:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1986Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 14:52:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-25-2020 14:52:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical Hi
story Term
:POST TRAUMATIC
STRESS DISORDE
R
Start Date: UNK/UNK/1980
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046037
Page 133 of 249
***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: 10061094 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 14:52:34
(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 14:52:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
POST TRAUMATIC STRESS DI
SORDERInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020 14:52:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020 14:52:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-01-2020 12:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe.mgrote)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:DIFFUSE SPAST
IC ESOPHAGUS
Start Date: UNK/UNK/2015
Ongoing: YESChanged
Information
Aug-25-2020 14:53:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046038
Page 134 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical His
tory Term:DIFFUSE SPASTI
C ESOPHAGITIS
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046039
Page 135 of 249
***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: 10061094 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 14:53:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
15:55:04
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Clo
sedDiscrepancy has
been closed.
Sep-01-2020
12:43:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredChanged
Information
Sep-01-2020
12:43:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Maddie Grote
(pfe mgrote)Data Entry:
DIFFUSE S
PASTIC ES
OPHAGUSChanged
Information
Aug-25-2020
22:59:58
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Op
enedClarify DIFFUSE
SPASTIC
ESOPHAGITIS
as follows...Term
is unclear. Are
you reporting
DIFFUSE
SPASM
ESOPHAGEAL?
Or
ESOPHAGITIS?
Or other? Please
update the
verbatim term to
clarify. Thank
you.
Aug-25-2020 ACV0PFEINFP6000  Maddie Grote Data Entry: Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046040
Page 136 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
14:53:17
(UTC-07:00)
Mountain Time
(US & Canada)(pfe mgrote) DIFFUSE S
PASTIC ES
OPHAGITIS
1.h Start Date:
Date Location User Value Reason
Aug-25-2020 14:53:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020 14:53:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-25-2020 14:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:ORAL COLD S
ORES
Start Date: UNK/UNK/199
5
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046041
Page 137 of 249
***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: 10061094 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 14:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 02:06:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Closed Response satisfies
query
Oct-27-2020 16:09:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 1: Answered No active cold sores
at time of study
entry per Physical
Exam performed.
Oct-24-2020 22:01:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Samuel
Dychter
(pfe.dychts)Query 1: Opened GPD Clin: Did the
subject have active
cold sores when
entering the study
or are if not present,
was it intermittent?
Aug-25-2020 14:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
ORAL COLD SORESInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020 14:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1995Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020 14:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046042
Page 138 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.j
Date Location User Value Reason
Aug-25-2020 14:54:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:ATTENTION DEFI
CIT DISORDER
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:54:43
(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 14:54:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
ATTENTION DEFICIT DISORD
ERInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-25-2020 14:54:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1998Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-25-2020 14:54:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046043
Page 139 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-25-2020 14:55:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:TEMPORPMANDIB
ULAR JOINT DYSF
UNCTION
Start Date
:UNK/UNK/2003
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:55:21
(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 14:55:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
TEMPORPMANDIBULAR JOI
NT DYSFUNCTIONInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-25-2020 14:55:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2003Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-25-2020 14:55:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-25-2020 14:56:05 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046044
Page 140 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00) Mountain
Time (US & Canada)(autocalc) Line/MH Nu
mber:12
Medical Histo
ry Term:NISSEN FUNDIP
LICATION
Start Date: UNK/UNK/2009
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:56:05
(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 14:56:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NISSEN FUNDIPLICATIONInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-25-2020 14:56:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2009Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-25-2020 14:56:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-25-2020 14:56:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:13Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046045
Page 141 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Hi
story Term
:GASTROESOPHAG
EAL REFLUX DISE
ASE
Start Date: UNK/UNK/1986
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:56:31
(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 14:56:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
GASTROESOPHAGEAL REFL
UX DISEASEInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-25-2020 14:56:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1986Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-25-2020 14:56:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-25-2020 14:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical Histor
y Term:DEVIATED SE
PTUMInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046046
Page 142 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Start Date: UNK/UNK/198
7
Ongoing: NO
End Date:
UNK/UNK/2
004
1.n Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:57:24
(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 14:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
DEVIATED SEPTUMInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-25-2020 14:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1987Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-25-2020 14:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.o
Date Location User Value Reason
Aug-25-2020 16:02:41 ACV0PFEINFP6000  Maddie Data Entry: Changed
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046047
Page 143 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00) Mountain
Time (US & Canada)Grote
(pfe.mgrote)Line/MH Numb
er:15
Medical History
Term:HEART MUR
MUR
Start Date: UNK/UNK/2
019
Ongoing: YESInformation
Aug-25-2020 14:58:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:15
Medical History
Term:HEART MUR
MUR
Start Date: UNK/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046048
Page 144 of 249
***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: 10061094 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 14:58:20
(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 14:58:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
HEART MURMURInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-25-2020 16:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 16:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2019Changed
Information
Aug-25-2020 16:00:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
24/Aug/2020.
Please review and
update as
appropriate.
Aug-25-2020 14:58:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe.mgrote)Data Entry:
UNK/UNK/2020Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-25-2020 14:58:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046049
Page 145 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.p
Date Location User Value Reason
Aug-25-2020 14:58:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:DEVIATED SEPT
UM REPAIR
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/200
4Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046050
Page 146 of 249
***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: 10061094 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 14:58:57
(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 14:58:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
DEVIATED SEPTUM REPAIRInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-25-2020 14:58:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/2004Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-25-2020 14:58:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.q
Date Location User Value Reason
Aug-27-2020 09:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:17
Medical History T
erm:ACNE (FACI
AL)
Start Date: UNK/UNK/1
998
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046051
Page 147 of 249
***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: 10061094 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-27-2020 09:45:34
(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 09:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
ACNE (FACIAL)Initial Entry
1.q Start Date:
Date Location User Value Reason
Aug-27-2020 09:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1998Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046052
Page 148 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.q Ongoing:
Date Location User Value Reason
Aug-27-2020 09:45:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Aug-27-2020 09:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:18
Medical Histo
ry Term:AMOXICILLIN
ALLERGY
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046053
Page 149 of 249
***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: 10061094 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-27-2020 09:45:58
(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-27-2020 09:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
AMOXICILLIN ALLERGYInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-27-2020 09:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1990Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-27-2020 09:45:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Aug-27-2020 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:19
Medical Hi
story Term
:IODINATED CONT
RAST MEDIA ALL
ERGY
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046054
Page 150 of 249
***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: 10061094 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-27-2020 09:46:33
(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-27-2020 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
IODINATED CONTRAST MEDI
A ALLERGYInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-27-2020 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1990Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-27-2020 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Aug-27-2020 09:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:20
Medical Histo
ry Term:PENICILLIN G
ALLERGY
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046055
Page 151 of 249
***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: 10061094 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-27-2020 09:46:57
(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-27-2020 09:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
PENICILLIN G ALLERGYInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-27-2020 09:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
UNK/UNK/1990Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-27-2020 09:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Oct-21-2020 15:24:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:21
Medical Histor
y Term:RECURRENT SI
NUSITIS
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046056
Page 152 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.u Line/MH Number:
Date Location User Value Reason
Oct-21-2020 15:24:01
(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
Oct-21-2020 15:24:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
RECURRENT SINUSITISInitial Entry
1.u Start Date:
Date Location User Value Reason
Oct-21-2020 15:24:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
UNK/UNK/2010Initial Entry
1.u Ongoing:
Date Location User Value Reason
Oct-21-2020 15:24:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046057
Page 153 of 249
***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: 10061094 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 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
137.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) MountainACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.3Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046058
Page 154 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Record Identifier:
:1
Temperature: 98.1
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 14:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046059
Page 155 of 249
***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: 10061094 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 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046060
Page 156 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020 14:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046061
Page 157 of 249
***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: 10061094 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 15:59:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 15:59:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
61617Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046062
Page 158 of 249
***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: 10061094 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 15:59:38
(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 15:59:38
(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 08:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 21:44:01
(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 appropriate.
Aug-25-2020 15:59:38
(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 15:59:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe.mgrote)Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046063
Page 159 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a
Date Location User Value Reason
Aug-26-2020 08:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2Y9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 08:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2Y9Initial Entry
5.b
Date Location User Value Reason
Aug-26-2020 08:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2YBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 08:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2YBInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 08:30:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2YCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 08:30:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2YCInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046064
Page 160 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Aug-26-2020 08:34:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7LY9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 08:34:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7LY9Initial Entry
5.e
Date Location User Value Reason
Aug-26-2020 08:34:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BJ7LYBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 08:34:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BJ7LYBInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046065
Page 161 of 249
***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: 10061094 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 15:59:56
(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 15:59:56
(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 08:31:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 21:43:48
(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 appropriate.
Aug-25-2020 15:59:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 15:59:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe.mgrote)Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046066
Page 162 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a
Date Location User Value Reason
Aug-26-2020 08:31:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BHV2PVInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 08:31:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
BHV2PVInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046067
Page 163 of 249
***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: 10061094 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 16:00:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 16:00:34
(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 16:00:34
(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 16:00:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
Aug/24/2020 09:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 16:00:34
(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 16:00:34
(UTC-07:00) MountainACV0PFEINFP6000  Maddie
GroteData Entry:
LEFTInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046068
Page 164 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe mgrote)
7. Route:
Date Location User Value Reason
Aug-25-2020 16:00:34
(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 16:00:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 16:00:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046069
Page 165 of 249
***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: 10061094 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 16:00:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Maddie
Grote
(pfe mgrote)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046070
Page 166 of 249
***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: 10061094 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-23-2020
13:12:25
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query
2: Clos
edResponse satisfies
query
Oct-23-2020
12:42:25
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query
2: Ans
weredOriginal value is
correct
Oct-22-2020
04:19:20
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
2: Ope
nedDMW5127505;The
Date of Visit at
Visit V2_VAX2_L
is the same as the
other Date of Visit
at Visit COVID_A.
Please review for
duplication and
update as
appropriate.
Sep-23-2020
01:53:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Pankaj Bhoir
(pfe.bhoirp02)Query
1: Clos
edResponse satisfies
query
Sep-22-2020
15:01:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query
1: Ans
weredConfirm visit
OOW, protocol
deviation to be
submitted
Sep-21-2020
03:05:52ACV0PFEINFP6000  Amol Shinde
(pfe.shinda18)Query
1: OpePDQ: DOV at this
visit is out of
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046071
Page 167 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00)
Mountain
Time (US &
Canada)ned window (2 day)
from DOV (24/Aug
/2020) at
V1D1VX1L.
Please either
update DOV or
confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-18-2020
14:37:24
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data E
ntry:
Sep/18/
2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046072
Page 168 of 249
***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: 10061094 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-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Record Identifier:
:1
Temperature: 97.5
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
FInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046073
Page 169 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 14:37:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046074
Page 170 of 249
***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: 10061094 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-18-2020 14:37:50
(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-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046075
Page 171 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 14:37:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046076
Page 172 of 249
***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: 10061094 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-18-2020 12:50:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 12:50:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 14:22:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Oct-23-2020 14:22:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened 'Sample Collected?'
is marked as No
and 'If no sample
was collected or
sample was not
collected according
to protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Oct-23-2020 14:22:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOChanged
Information
Oct-23-2020 13:40:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Carrie
Nedrick
(pfe.nedrickc)Query 3: Closed Response satisfies
query
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046077
Page 173 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-23-2020 12:43:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Query 3: Answered V2 Swab captured
on COVID_A Visit
Oct-22-2020 08:57:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Carrie
Nedrick
(pfe.nedrickc)Query 3: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 17:19:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 17:19:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-21-2020 15:44:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 12:51:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 12:50:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 12:50:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046078
Page 174 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-23-2020 14:22:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
SAMPLE CAPTURED IN COVI
D ILLNESS VISIT AInitial Entry
5.a
Date Location User Value Reason
Oct-21-2020 17:19:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BH2422Swab barcode
captured in Potential
COVID-19 Illness A
(DELETED)
Oct-21-2020 17:19:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BH2422Initial Entry
Oct-21-2020 15:44:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID:Swab barcode
captured on
Potential COVID-19
Illness A.
Sep-18-2020 12:51:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BH2422Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-25-2020
01:54:44
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Vijay Venugopal
(pfe.venugv04)Query
1: Clos
edResponse satisfies
query
Oct-23-2020
12:51:17
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query
1: Ans
weredBARCODE
DELETED FROM
V2
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046079
Page 175 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-21-2020
20:46:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW5127319;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Oct-21-2020
17:19:51
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data E
ntry:
BH242
2Swab barcode
captured in
Potential
COVID-19 Illness
A (DELETED)
Oct-21-2020
17:19:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data E
ntry:
BH242
2Initial Entry
Oct-21-2020
15:44:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data E
ntry:Swab barcode
captured on
Potential
COVID-19 Illness
A.
Sep-18-2020
12:51:03
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data E
ntry:
BH242
2Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046080
Page 176 of 249
***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: 10061094 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-18-2020 14:38:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 14:38:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 14:38:40
(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-18-2020 14:38:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
Sep/18/2020 13:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 14:38:40
(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-18-2020 14:38:40
(UTC-07:00) MountainACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
LEFTInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046081
Page 177 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-18-2020 14:38:40
(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-18-2020 14:38:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 14:38:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ty Henry
(pfe.thenry)Data Entry:
YESInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046082
Page 178 of 249
***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: 10061094 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-16-2020 14:54:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ashley
Bragg
(pfe.abragg)Data Entry:
Oct/16/2020Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046083
Page 179 of 249
***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: 10061094 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-16-2020 14:55:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 14:55:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 18:22:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 14:55:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 14:55:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ashley
Bragg
(pfe.abragg)Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 18:22:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BCT8DRInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046084
Page 180 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 18:22:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BCT8DRInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 18:22:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BJ7M85Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 18:22:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BJ7M85Initial Entry
5.c
Date Location User Value Reason
Oct-16-2020 18:22:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
Sample ID: BJ7MF6Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 18:22:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Colby
Bostock
(pfe.cbostock)Data Entry:
BJ7MF6Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046085
Page 181 of 249
***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: 10061094 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-12-2021 11:07:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
Mar/12/2021Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046086
Page 182 of 249
***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: 10061094 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-12-2021 11:08:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021 11:08:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021 11:09:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-12-2021 11:08:03
(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-12-2021 11:08:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021 11:09:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
Sample ID: BRBMG0Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046087
Page 183 of 249
***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: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Mar-12-2021 11:09:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
BRBMG0Initial Entry
5.b
Date Location User Value Reason
Mar-12-2021 11:09:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
Sample ID: BS8WM8Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021 11:09:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
BS8WM8Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021 11:10:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
Sample ID: BS8WPNInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021 11:10:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Bradley
Young
(pfe.byoung)Data Entry:
BS8WPNInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046088
Page 184 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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-23-2020
13:14:36
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Pamela Benne prod
(pfe.bennep07)Query
3: Clos
edResponse satisfies
query
Oct-23-2020
12:44:10
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query
3: Ans
weredOriginal value is
correct
Oct-22-2020
04:19:20
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
3: Ope
nedDMW5127504;The
Date of Visit at
Visit COVID_A is
the same as the
other Date of Visit
at Visit
V2_VAX2_L.
Please review for
duplication and
update as
appropriate.
Oct-21-2020
15:34:11
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Dele
tedClose Auto Query
Oct-21-2020
15:32:16
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Dele
tedClose Auto Query
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046089
Page 185 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-21-2020
15:31:31
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Cand
idateDate of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-21-2020
15:31:31
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Cand
idateDate of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Oct-21-2020
15:31:31
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data E
ntry:
Sep/18/
2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-21-2020 15:31:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046090
Page 186 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-21-2020 15:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there is
no Other Symptom
reported. Please
review and update
as appropriate.
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sep/18/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sep/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NO
Date of Last Symptom Resolved
:
Sep/15/2020Initial Entry
4.a
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) MountainACV0PFEINFP6000  Lindsey
BevanData Entry: Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046091
Page 187 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.lbevan) Symptoms: FEVER
Symptom Present: NO
4.a Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.c
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046092
Page 188 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046093
Page 189 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.d Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046094
Page 190 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046095
Page 191 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.g Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms: VOMITINGInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046096
Page 192 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptom Present: NO
4.i Symptoms:
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:32:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-21-2020 15:32:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms -
Other:NASAL CONGE
STIONTranscription Error
Oct-21-2020 15:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms -
Other:NASAL DISCH
ARGEInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-21-2020 15:32:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NASAL CONGESTIONTranscription Error
Oct-21-2020 15:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NASAL DISCHARGEInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046097
Page 193 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-23-2020 12:45:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptom
s - Other:NASAL DISCHARG
E DISCOLORATIO
NChanged
Information
Oct-21-2020 15:32:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Symptoms -
Other:DISCOLORED
MUCUSInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046098
Page 194 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Symptoms - Other Text:
Date Location User Value Reason
Oct-23-2020
21:42:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: C
losedDiscrepancy has
been closed.
Oct-23-2020
12:45:27
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredChanged
Information
Oct-23-2020
12:45:27
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entr
y:
NASAL D
ISCHARG
E DISCOL
ORATIONChanged
Information
Oct-22-2020
02:07:27
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: O
penedClarify
DISCOLORED
MUCUS as
follows...The term is
ambiguous. Are you
reporting NASAL
DISCHARGE
DISCOLORATION?
SPUTUM
DISCOLORED? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
term. Thank you.
Oct-21-2020
15:32:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entr
y:
DISCOLO
RED MUC
USInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046099
Page 195 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046100
Page 196 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-21-2020 15:33:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Not DoneInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046101
Page 197 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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-21-2020 15:33:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 15:33:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 15:33:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-21-2020 15:33:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
SWAB PFE COLLECTED AT VI
SIT 2Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046102
Page 198 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 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-21-2020 15:34:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 15:34:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 15:34:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 15:34:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 15:34:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 15:34:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Sample ID: BH2422Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046103
Page 199 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User ValueReason
Oct-23-2020
13:41:13
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Carrie Nedrick
(pfe.nedrickc)Query
2: Clo
sedResponse satisfies
query
Oct-23-2020
12:45:58
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Query
2: An
swere
dBARCODE
DELETED FOR V2
Oct-22-2020
23:41:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Saumitra Dubey
(pfe.dubeys27)Query
2: Op
enedHOLDS query: As
per LAB, NASAL
SWAB sample with
barcode BH2422 is
received for visit
V2_VAX2_L. If
InForm data is
correct kindly submit
SCF to update the
visit in Lab. Else
clarify.
Oct-22-2020
01:44:43
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Oct-21-2020
20:46:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW5127318;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Oct-21-2020
15:34:17ACV0PFEINFP6000  Lindsey Bevan
(pfe.lbevan)Data
EntryInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046104
Page 200 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-07:00)
Mountain
Time (US &
Canada):
BH24
22
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046105
Page 201 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046106
Page 202 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practit
ioner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1Initial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
090177e196ae3d40\Final\Final On: 01-Apr-2021 04:28 (GMT)
FDA-CBER-2021-5683-0046107
Page 203 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/18/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061094 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-21-2020 15:34:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Lindsey
Bevan
(pfe.lbevan)Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae
…[truncated]