Document text
Page 1 of 507
***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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045140
Page 2 of 507
***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: 10061040 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/14/2020
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045141
Page 3 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10061040]
2.Birth Date: /1994
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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045142
Page 4 of 507
***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: 10061040 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/14/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045143
Page 5 of 507
***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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045144
Page 6 of 507
***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: 10061040 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/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045145
Page 7 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10061040 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:[Migraine headaches]
Start Date: Aug/30/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BRCA1 CANCER GENE CARRIER]
Start Date: Nov/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent muscle spasm neck and back]
Start Date: Aug/23/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Disorder of trigeminal nerve]
Start Date: Aug/16/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major depressive disorder]
Start Date: Jul/13/2018
Ongoing: YES
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045146
Page 8 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dorsopathies occipito-atlanto-axial region]
Start Date: Aug/16/2019
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intolerance Reglan]
Start Date: UNK/UNK/2016
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurring tonsilitis]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
Dec/28/2020
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045147
Page 9 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [168.0]
3.Unit: LB
4.Height: [60.0]
5.Unit: in
6.Body Mass Index: [32.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045148
Page 10 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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/14/2020
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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045149
Page 11 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50870]
3.Randomization Group: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045150
Page 12 of 507
***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: 10061040 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/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHV2SP]
5.bSample ID [BHV2SR]
5.cSample ID [BHV2SS]
5.dSample ID [BLZ8CH]
5.eSample ID [BLZ8CJ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045151
Page 13 of 507
***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: 10061040 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/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHV2N7]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045152
Page 14 of 507
***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: 10061040 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/14/2020 18:17
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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045153
Page 15 of 507
***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: 10061040 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 collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045154
Page 16 of 507
***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: 10061040 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/4/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045155
Page 17 of 507
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/21/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045156
Page 18 of 507
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045157
Page 19 of 507
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045158
Page 20 of 507
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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/4/2020
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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045159
Page 21 of 507
***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: 10061040 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/4/2020
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 [BCT8GP]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045160
Page 22 of 507
***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: 10061040 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/4/2020 17:35
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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045161
Page 23 of 507
***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: 10061040 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/2/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045162
Page 24 of 507
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045163
Page 25 of 507
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045164
Page 26 of 507
***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: 10061040 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/2/2020
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 [BCT8B4]
5.bSample ID [BJ7M5L]
5.cSample ID [BJ7MBM]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045165
Page 27 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045166
Page 28 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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/23/2020
2.Date of First Symptom Started: Sep/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/23/2020
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? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045167
Page 29 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045168
Page 30 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045169
Page 31 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045170
Page 32 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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:[PI deemed swab not be collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045171
Page 33 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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:[PI deemed swab not necessary]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045172
Page 34 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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: NO
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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045173
Page 35 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045174
Page 36 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045175
Page 37 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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?NO
3.Toxicity Grade: 2 Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045176
FDA-CBER-2021-5683-0045177
Page 39 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045178
Page 40 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045179
Page 41 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045180
Page 42 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045181
Page 43 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045182
FDA-CBER-2021-5683-0045183
Page 45 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045184
FDA-CBER-2021-5683-0045185
Page 47 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 % [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045186
FDA-CBER-2021-5683-0045187
Page 49 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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): [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045188
Page 50 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045189
Page 51 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045190
FDA-CBER-2021-5683-0045191
Page 53 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045192
Page 54 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045193
Page 55 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: Oct/12/2020
2.Date of First Symptom Started: Sep/30/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/28/2020
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045194
Page 56 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045195
Page 57 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/3/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045196
Page 58 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/3/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045197
Page 59 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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? YES
Date of Collection:
Oct/12/2020
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 [RW89374]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045198
Page 60 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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:[Telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045199
Page 61 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045200
FDA-CBER-2021-5683-0045201
Page 63 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045202
Page 64 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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:
[Strep throat]
Date of Diagnosis:
Oct/8/2020
3.Toxicity Grade: 2
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045203
FDA-CBER-2021-5683-0045204
Page 66 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045205
Page 67 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045206
Page 68 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045207
Page 69 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045208
Page 70 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045209
FDA-CBER-2021-5683-0045210
Page 72 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045211
FDA-CBER-2021-5683-0045212
Page 74 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 % [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045213
FDA-CBER-2021-5683-0045214
Page 76 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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): [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045215
Page 77 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045216
Page 78 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045217
FDA-CBER-2021-5683-0045218
Page 80 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/12/2020Form: 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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045219
Page 81 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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 Nov/20/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045220
Page 82 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045221
Page 83 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045222
Page 84 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045223
Page 85 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045224
Page 86 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045225
Page 87 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045226
Page 88 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045227
Page 89 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Applicable Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045228
FDA-CBER-2021-5683-0045229
Page 91 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045230
Page 92 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045231
FDA-CBER-2021-5683-0045232
Page 94 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045233
Page 95 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045234
Page 96 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045235
Page 97 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045236
Page 98 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045237
FDA-CBER-2021-5683-0045238
Page 100 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045239
FDA-CBER-2021-5683-0045240
Page 102 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 % [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045241
FDA-CBER-2021-5683-0045242
Page 104 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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): [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045243
Page 105 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045244
Page 106 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045245
FDA-CBER-2021-5683-0045246
Page 108 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: 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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045247
Page 109 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/23/2020Form: 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: 10061040 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/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045248
Page 110 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/23/2020Form: 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: 10061040 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/23/2020
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 [BH2445]
5.bSample ID [BSJPKH]
5.cSample ID [BJ7MGB]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045249
Page 111 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/13/2020Form: 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: 10061040 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 Nov/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045250
Page 112 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/13/2020Form: 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: 10061040 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:
Nov/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BH245B]
5.bSample ID [BSJPV0]
5.cSample ID [BSJPLN]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045251
Page 113 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Dec/18/2020Form: 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: 10061040 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 Dec/18/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1 Comments
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045252
Page 114 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Dec/18/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045253
Page 115 of 507
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/18/2020Form: 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: 10061040 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/18/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045254
Page 116 of 507
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/18/2020Form: UNPLANNED VISIT
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045255
Page 117 of 507
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/18/2020Form: CONTACT OUTCOME - UNPLANNED
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/18/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045256
Page 118 of 507
***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: 10061040 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/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045257
Page 119 of 507
***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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045258
Page 120 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Nov/20/2020Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 Nov/20/2020
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: COVID_BR1
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045259
Page 121 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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? YES
Date of Collection:
Nov/20/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV44430]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045260
Page 122 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
1. ADVERSE E
VENT 1 Strep throat Sep/8/2020 UN
K:UNK NO
End Date Time:
Sep/18/2020 UNK:U
NK
Repeating
Pages
2. DELETED ADVERSE E
VENT 2 DIARRHEA Sep/18/2020 U
NK:UNK NO
End Date Time:
Sep/23/2020 UNK:U
NK
Repeating
Pages
3. ADVERSE E
VENT 3 Clostridium Difficil
e Infection Sep/30/2020 U
NK:UNK NO
End Date Time:
Feb/28/2021 UNK:U
NK
Repeating
Pages
4. ADVERSE E
VENT 4 Injection Site Pain Dec/18/2020 19:
00 NO
End Date Time:
Dec/20/2020 UNK:U
NK
Repeating
Pages
5. ADVERSE E
VENT 5 Post Surgical Pain Dec/28/2020 U
NK:UNK NO
End Date Time:
Jan/12/2021 UNK:U
NK
Repeating
Pages
6. ADVERSE E
VENT 6 Exposure During Pr
egnancy Feb/8/2021 UN
K:UNK YES Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045261
Page 123 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Strep throat]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 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:
[bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045262
Page 124 of 507
***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: 10061040 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[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045263
Page 125 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[DIARRHEA ]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/23/2020 UNK:UNK
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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[TRAVELER'S DIARRHEA ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045264
Page 126 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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?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[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045265
Page 127 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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)[Clostridium Difficile Infection]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/28/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Multiple antibiotics]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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[ ]
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FDA-CBER-2021-5683-0045267
Page 129 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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)[Injection Site Pain]
4.Start Date Time: Dec/18/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/20/2020 UNK:UNK
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
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
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Page 130 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
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FDA-CBER-2021-5683-0045269
Page 131 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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)[Post Surgical Pain]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/12/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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:
[Tonsillectomy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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Page 132 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045271
Page 133 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Exposure During Pregnancy]
4.Start Date Time: Feb/8/2021 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:
[Stopped birth control]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045272
Page 134 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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[ ]
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FDA-CBER-2021-5683-0045273
Page 135 of 507
***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: 10061040 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
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Page 136 of 507
***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: 10061040 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[ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045275
Page 137 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Medic
ationStart D
ateForm Instan
ce
1. DELETED 1 VACCINATIO
NS NO penicillin/ 500 m
g/BID/PO Sep/9/2
020 Repeating
Pages
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045276
Page 138 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[penicillin/ 500 mg/BID/PO ]
5.Date: Sep/9/2020
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Page 139 of 507
***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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045278
Page 140 of 507
***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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045279
FDA-CBER-2021-5683-0045280
Page 142 of 507
***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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045281
FDA-CBER-2021-5683-0045282
Page 144 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045283
Page 145 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045284
Page 146 of 507
***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: 10061040 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:
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FDA-CBER-2021-5683-0045285
Page 147 of 507
***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: 10061040 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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045286
Page 148 of 507
***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: 10061040 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?
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045287
Page 149 of 507
***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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045288
Page 150 of 507
***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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045289
Page 151 of 507
***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: 10061040 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 Dec/15/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045290
Page 152 of 507
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045291
Page 153 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10061040 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 Dec/18/2020
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045292
Page 154 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
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FDA-CBER-2021-5683-0045293
Page 155 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045294
Page 156 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045295
Page 157 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: Dec/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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045296
Page 158 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10061040 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:
Dec/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 [BCSY34]
5.bSample ID [BS8WJB]
5.cSample ID [BJ7MKK]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045297
Page 159 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10061040 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:
Dec/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Sample collected under COVID_C1]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRL0P9]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045298
Page 160 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 16:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045299
Page 161 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045300
Page 162 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045301
Page 163 of 507
***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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045302
Page 164 of 507
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045303
Page 165 of 507
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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: Jan/8/2021
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:
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045304
Page 166 of 507
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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:
Jan/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBCDS]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045305
Page 167 of 507
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/8/2021 13:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045306
Page 168 of 507
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: 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: 10061040 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/8/2021
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045307
Page 169 of 507
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/8/2021
3.Comments: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045308
Page 170 of 507
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045309
Page 171 of 507
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045310
Page 172 of 507
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045311
Page 173 of 507
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 10061040 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: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045312
Page 174 of 507
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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 :Feb/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045313
Page 175 of 507
***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: 10061040 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/2/2020
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045314
Page 176 of 507
***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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045315
Page 177 of 507
***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: 10061040 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
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045316
Page 178 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-15-2020 09:42:13 (UTC-07:00) Mountain
Time (US & Canada)Heather Littell
(pfe hlittell)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045317
Page 179 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045318
Page 180 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045319
Page 181 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045320
Page 182 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045321
Page 183 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045322
Page 184 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045323
Page 185 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045324
Page 186 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045325
Page 187 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045326
Page 188 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: 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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Oct-12-2020 17:09:00 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045327
Page 189 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
FormOct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
FormOct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045328
Page 190 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
1Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
1Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045329
Page 191 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
2Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
2Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045330
Page 192 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
3Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
3Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045331
Page 193 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
4Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
4Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045332
Page 194 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
5Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
5Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045333
Page 195 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Oct-15-2020 15:17:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
6Oct-15-2020 09:15:37 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
6Oct-15-2020 09:11:05 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045334
Page 196 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-04-2020 08:55:05 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
3Oct-12-2020 17:10:59 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)PI deemed swab not necessary and did not assign
toxicity
Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045335
Page 197 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-15-2020 15:17:25 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
FormOct-15-2020 09:16:24 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
FormOct-15-2020 09:14:28 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045336
Page 198 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Oct-15-2020 15:17:25 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
1Oct-15-2020 09:16:24 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
1Oct-15-2020 09:14:28 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045337
Page 199 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Oct-15-2020 15:17:25 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
2Oct-15-2020 09:16:24 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
2Oct-15-2020 09:14:28 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045338
Page 200 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Oct-15-2020 15:17:25 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
3Oct-15-2020 09:16:24 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
3Oct-15-2020 09:14:28 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045339
Page 201 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Oct-15-2020 15:17:25 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
4Oct-15-2020 09:16:24 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)
4Oct-15-2020 09:14:28 (UTC-07:00) Mountain
Time (US & Canada)Colby Bostock
(pfe.cbostock)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045340
Page 202 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045341
Page 203 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045342
Page 204 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045343
Page 205 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045344
Page 206 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.aNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045345
Page 207 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.bNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045346
Page 208 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.cNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045347
Page 209 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.dNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045348
Page 210 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.eNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045349
Page 211 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4 fNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045350
Page 212 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.gNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045351
Page 213 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4 hNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045352
Page 214 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.iNov-25-2020 11:43:11 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045353
Page 215 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045354
Page 216 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045355
Page 217 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045356
Page 218 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045357
Page 219 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045358
Page 220 of 507
***Confidential***
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045359
Page 221 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045360
Page 222 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045361
Page 223 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045362
Page 224 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Nov-20-2020 16:58:49 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Done
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045363
Page 225 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-30-2020 09:07:50 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
FormNov-25-2020 16:02:47 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045364
Page 226 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-30-2020 09:07:50 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045365
Page 227 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-30-2020 09:07:50 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045366
Page 228 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-30-2020 09:07:50 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045367
Page 229 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-30-2020 09:07:50 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045368
Page 230 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-25-2020 11:38:05 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045369
Page 231 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-25-2020 11:38:05 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045370
Page 232 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-25-2020 11:38:05 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045371
Page 233 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-25-2020 11:38:05 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045372
Page 234 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Nov-25-2020 11:38:05 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045373
Page 235 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045374
Page 236 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.aNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045375
Page 237 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.bNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045376
Page 238 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.cNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045377
Page 239 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.dNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045378
Page 240 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.eNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045379
Page 241 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1 fNov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045380
Page 242 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045381
Page 243 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-25-2020 12:39:39 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045382
Page 244 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Nov/20/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormNov-25-2020 12:40:13 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045383
Page 245 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Nov-25-2020 12:40:13 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045384
Page 246 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Nov-25-2020 12:40:13 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045385
Page 247 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-25-2020 12:40:13 (UTC-07:00) Mountain
Time (US & Canada)Bradley Young
(pfe.byoung)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045386
Page 248 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-02-2021 13:14:55 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
3Jan-19-2021 11:43:32 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
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090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045387
Page 249 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Dec/18/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-09-2021 11:59:36 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
FormJan-21-2021 09:55:48 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
FormJan-19-2021 11:57:48 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045388
Page 250 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-09-2021 11:59:36 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
1Jan-21-2021 09:55:48 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
1Jan-19-2021 11:57:48 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045389
Page 251 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-09-2021 11:59:36 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
2Jan-21-2021 09:55:48 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
2Jan-19-2021 11:57:48 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045390
Page 252 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-09-2021 11:59:36 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
3Jan-21-2021 09:55:48 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
3Jan-19-2021 11:57:48 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045391
Page 253 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Mar-09-2021 11:59:36 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
4Jan-21-2021 09:55:48 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)
4Jan-19-2021 11:57:48 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045392
Page 254 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Mar-04-2021 13:12:47 (UTC-07:00) Mountain
Time (US & Canada)Lindsey Bevan
(pfe.lbevan)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045393
Page 255 of 507
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormDec-18-2020 16:50:28 (UTC-07:00) Mountain
Time (US & Canada)Emily Wilcox
(pfe.ewilcox)Not Applicable
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045394
Page 256 of 507
***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: 10061040 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 Feb-09-2021 11:08:16 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Jan-22-2021 18:47:15 (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 Dec-04-2020 14:03:43 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Dec-02-2020 17:28:40 (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.
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045395
Page 257 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lindsey Bevan N/A Dec-02-2020 16:46:06 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Dec-01-2020 17:43:53 (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 Nov-27-2020 13:20:22 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Nov-25-2020 18:56:22 (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 Nov-20-2020 16:53:09 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Nov-13-2020 17:26:31 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045396
Page 258 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, JamesPeterson, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Megan
Grimmett N/A Nov-12-2020 14:35:33 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Nov-05-2020 09:29:47 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesPeterson, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Lindsey Bevan N/A Nov-04-2020 08:55:05 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Oct-23-2020 18:06:05 (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.
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045397
Page 259 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lindsey Bevan N/A Oct-23-2020 17:15:13 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
James Peterson Approved Oct-16-2020 12:46:17 (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.
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045398
Page 260 of 507
***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: 10061040 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-15-2020 09:40:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-15-2020 09:40:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045399
Page 261 of 507
***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: 10061040 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-15-2020 09:40:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045400
Page 262 of 507
***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: 10061040 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-15-2020 09:39:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10061040Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-15-2020 09:39:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020 09:40:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 09:40:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)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-15-2020 09:40:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
WHITEInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
FDA-CBER-2021-5683-0045401
Page 263 of 507
***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: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-15-2020 09:41:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/14/2020Initial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045402
Page 264 of 507
***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: 10061040 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-15-2020 09:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-15-2020 09:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-15-2020 09:42:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045403
Page 265 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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-15-2020 09:43:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Migraine heada
ches
Start Date: Aug/30/2016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-15-2020 09:43:43
(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-15-2020 09:43:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Migraine headachesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-15-2020 09:43:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/30/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-15-2020 09:43:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.b
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045404
Page 266 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-15-2020 11:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:BRCA1 CANCER
GENE CARRIER
Start Date: Nov/UNK/2018
Ongoing: YESChanged
Information
Aug-15-2020 09:44:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:BRCA1 Posit
ive
Start Date: Nov/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045405
Page 267 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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-15-2020 09:44:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-15-2020
12:28:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Clo
sedDiscrepancy has
been closed.
Aug-15-2020
11:46:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged
Information
Aug-15-2020
11:46:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
BRCA1 CA
NCER GEN
E CARRIERChanged
Information
Aug-15-2020
11:36:37
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Ope
nedClarify BRCA1
POSITIVE as
follows...The term
appears incomplete.
Are you reporting
BRCA1 GENE
MUTATION?
BRCA1 CANCER
GENE CARRIER?
BRCA1 GENE
MUTATION
ASSAY
IDENTIFICATION
TEST POSITIVE?
BRCA1 POSITIVE
BREAST
CANCER? If so,
update the verbatim
term as such.
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045406
Page 268 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Otherwise clarify
and edit the term.
Thank you.
Aug-15-2020
09:44:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Heather Littell
(pfe hlittell)Data Entry:
BRCA1 Posit
iveInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-15-2020 09:44:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Nov/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-15-2020 09:44:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-15-2020 09:48:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Intermittent muscle s
pasm neck and back
Start Date: Aug/23/2019
Ongoing: YESInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045407
Page 269 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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-15-2020 09:48:06
(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-15-2020 09:48:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Intermittent muscle spasm neck an
d backInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-15-2020 09:48:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/23/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-15-2020 09:48:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-15-2020 09:48:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:Disorder of trigem
inal nerve
Start Date: Aug/16/2019
Ongoing: YESInitial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045408
Page 270 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 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-15-2020 09:48:50
(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-15-2020 09:48:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Disorder of trigeminal nerveInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-15-2020 09:48:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/16/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-15-2020 09:48:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-16-2020 08:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Major depressive
disorder
Start Date: Jul/13/2018
Ongoing: YESclarification
Aug-15-2020 09:49:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5Initial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045409
Page 271 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histo
ry Term:Mild major depres
sive disorder
Start Date: Jul/13/2018
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-15-2020 09:49:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 08:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Major depressive disorderclarification
Aug-15-2020 09:49:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Mild major depressive disorderInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-15-2020 09:49:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Jul/13/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-15-2020 09:49:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-15-2020 09:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6Initial Entry
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045410
Page 272 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical His
tory Term:dorsopathies occipito
-atlanto-axial region
Start Date: Aug/16/2019
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-15-2020 09:50:12
(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-15-2020 09:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
dorsopathies occipito-atlanto-axial
regionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-15-2020 09:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Aug/16/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-15-2020 09:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-16-2020 14:08:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Intolerance Re
glan
Start Date: UNK/UNK/2
016Transcription Error
090177e196ae3d23\Final\Final On: 01-Apr-2021 04:27 (GMT)
FDA-CBER-2021-5683-0045411
Page 273 of 507
***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, Frozen, Verified
Site No: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic
Subject No: 10061040 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: YES
Sep-16-2020 08:22:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Intolerance Regla
n-jaw locked
Start Date: UNK/UNK/2016
Ongoing: YESNew Information
Sep-11-2020 12:25:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lindsey
Bevan
(pfe.lbevan)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Intolerance Re
glan
Start Date: UNK/UNK/2
016
Ongoing: YESTranscription Error
Sep-10-2020 09:09:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Heather
Littell
(pfe hlittell)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Intolerance Regla
n Jaw Locked
Start Date: UNK/UNK/2016
Ongoing: YESNew Information
Aug-15-20
…[truncated]