Document text
Page 1 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044080
Page 2 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Oct/19/2020
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044081
Page 3 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051293]
2.Birth Date: /1960
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044082
Page 4 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044083
Page 5 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044084
Page 6 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044085
Page 7 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:[OSTEOARTHRITIS]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIGH CHOLESTEROL]
Start Date: Jan/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VASECTOMY]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044086
Page 8 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CERVICAL FUSION]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT INGUINAL HERNIA REPAIR]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alcohol Use Disorder]
Start Date: UNK/UNK/1973
Ongoing: YES
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044087
Page 9 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044088
Page 10 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [206.6]
3.Unit: LB
4.Height: [72.3]
5.Unit: in
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044089
Page 11 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270739]
3.Randomization Group: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044090
Page 12 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ3W8K]
5.bSample ID [BJ3W8L]
5.cSample ID [BPB06J]
5.dSample ID [BPB06K]
5.eSample ID [BPB06L]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044091
Page 13 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:
Oct/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPB0J6]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044092
Page 14 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: Oct/19/2020 08:47
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
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044093
Page 15 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044094
Page 16 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044095
Page 17 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044096
Page 18 of 334
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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 Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044097
Page 19 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044098
Page 20 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044099
Page 21 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044100
Page 22 of 334
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044101
Page 23 of 334
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044102
Page 24 of 334
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044103
Page 25 of 334
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044104
Page 26 of 334
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044105
Page 27 of 334
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044106
Page 28 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044107
Page 29 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: Nov/9/2020
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO Comments
4.dSymptoms: CHILLS
Was symptom present? NO Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO Comments
4.hSymptoms: DIARRHEA
Was symptom present? NO Comments
4.iSymptoms: VOMITING
Was symptom present? NO Comments
Symptoms - Other
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044108
Page 30 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.Symptoms - Other Text: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044109
Page 31 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/8/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044110
Page 32 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: Nov/8/2020
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: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044111
Page 33 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:[UNABLE TO CONTACT SUBJECT AT THIS TIME TO OBTAIN SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044112
Page 34 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:[NOT ABLE TO COLLECT UNABLE TO CONTACT SUBJECT AT TIME]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044113
Page 35 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [HOSPITALIZED]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044114
FDA-CBER-2021-5683-0044115
Page 37 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Nov/8/2020
4.Ongoing? YES
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044116
Page 38 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatment TreatmentStart Da
teForm Instanc
e
1.1 YES MECHANICAL VENT
ILATION MECHANICAL VENT
ILATION Nov/8/2
020 Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044117
Page 39 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: MECHANICAL VENTILATION
4.Treatment: [MECHANICAL VENTILATION]
5.Start Date: Nov/8/2020
6.Ongoing? YES
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044118
Page 40 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:
[ACUTE RESPIRATORY FAILURE]
Date of Diagnosis:
Nov/8/2020
3.Toxicity Grade: 4
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044119
FDA-CBER-2021-5683-0044120
Page 42 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044121
Page 43 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor NameCollecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1.CLINICAL
CHEMISTR
Y Strong Memorial Labs 601 Elm
wood Avenue Rochester, NY 14
642 Nov/10/
2020 BLOO
D Sponsor-Defi
ned Identifie
rTest:Res
ult:
329 C Reactive Prote
in_PX329 [ ]
30 Alanine Aminotr
ansferase_PX30 64
28 Aspartate Amino
transferase_PX2
8 24
35 Alkaline Phosph
atase_PX35 61
21 Bilirubin_PX21 0.5
47 Blood Urea Nitr
ogen_PX47 12
48 Creatinine_PX4
8 0.79
Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044122
Page 44 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Strong Memorial Labs 601 Elmwood Avenue Rochester, NY 14642]
3.Collection Date: Nov/10/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [64]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044123
Page 45 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [24]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [61]
Not Done:
LNMT Low
[40]
High
[130]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.0]
High
[1.2]
Unit
mg/dL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044124
Page 46 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [12]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.79]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044125
Page 47 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY Strong Memorial Labs 601 Elmwo
od Avenue Rochester, NY 14642 Nov/10/2
020 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Hemoglobi
n_PX1 13.7
2 Hematocrit
_PX2 41
3 Erythrocyte
s_PX3 4.6
5 Platelets_P
X5 234
7 Leukocytes
_PX7 5.9
608 Neutrophils
_PX608 4.0
609 Eosinophils
_PX609 0.2
612 Monocytes
_PX612 0.4
610 Basophils_
PX610 0.1
611 Lymphocyt
es_PX611 1.3 Repeating
Pages
2.HEMATOL
OGY Strong Memorial Labs
601 Elmwood Avenue
Rochester, NY 14642 Nov/8/20
20 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Hemoglobi
n_PX1 15
2 Hematocrit
_PX2 [ ]
3 Erythrocyte
s_PX3 [ ]
5 Platelets_P
X5 303
7 Leukocytes
_PX7 11.2
608 Neutrophils
_PX608 [ ] Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044126
Page 48 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
Sponsor-Defi
ned IdentifierTest:Res
ult:
609 Eosinophils
_PX609 [ ]
612 Monocytes
_PX612 [ ]
610 Basophils_
PX610 [ ]
611 Lymphocyt
es_PX611 [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044127
Page 49 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Strong Memorial Labs 601 Elmwood Avenue Rochester, NY 14642]
3.Collection Date: Nov/10/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.7]
Not Done:
LNMT Low
[13.7]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [41]
Not Done:
LNMT Low
[40]
High
[51]
Unit
%
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044128
Page 50 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.6]
Not Done:
LNMT Low
[4.6]
High
[6.1]
Unit
10^3/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [234]
Not Done:
LNMT Low
[150]
High
[330]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.9]
Not Done:
LNMT Low
[4.2]
High
[9.1]
Unit
10^3/uL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044129
Page 51 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.0]
Not Done:
LNMT Low
[1.8]
High
[5.4]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.4]
Not Done:
LNMT Low
[0.3]
High
[0.8]
Unit
10^3/uL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044130
Page 52 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.3]
Not Done:
LNMT Low
[1.3]
High
[3.6]
Unit
10^3/uL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044131
Page 53 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Strong Memorial Labs
601 Elmwood Avenue
Rochester, NY 14642]
3.Collection Date: Nov/8/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15]
Not Done:
LNMT Low
[13.7]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044132
Page 54 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [303]
Not Done:
LNMT Low
[150]
High
[330]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [11.2]
Not Done:
LNMT Low
[4.2]
High
[9.1]
Unit
10^3/uL
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044133
Page 55 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044134
Page 56 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044135
FDA-CBER-2021-5683-0044136
Page 58 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [139]
Diastolic: [88]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [114]
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FDA-CBER-2021-5683-0044137
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044138
FDA-CBER-2021-5683-0044139
Page 61 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/8/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
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FDA-CBER-2021-5683-0044140
Page 62 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Vital Signs
1.Date: Nov/8/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044141
FDA-CBER-2021-5683-0044142
Page 64 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Nov/8/2020 UNK:UNK
2.Arterial Blood Gases PaO2 (mmHg): [80]
3.FiO2 (Fraction of Inhaled Oxygen): Unknown
[ ]Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044143
Page 65 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044144
Page 66 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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?
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FDA-CBER-2021-5683-0044145
Page 67 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Asse
ssmentLocation of Ass
essmentImaging M
ethodOverall AssessmentForm Instanc
e
1.Nov/8/2020 HEAD CT SCAN NORMAL Repeating
Pages
2.Nov/8/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Bilateral perihilar airspace & interstitial opacities -possible
pulmonary edema vs. infection
Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044146
Page 68 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/8/2020
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
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FDA-CBER-2021-5683-0044147
Page 69 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/8/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral perihilar airspace & interstitial opacities -possible pulmonary edema vs.
infection]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044148
Page 70 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044149
Page 71 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044150
Page 72 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044151
Page 73 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044152
Page 74 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 CARDIAC ARREST Nov/8/2020 00:
43 NO
End Date Time:
Nov/8/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Acute Respiratory Fail
ure Nov/8/2020 00:
43 YES Repeating
Pages
3.ADVERSE EVE
NT 3 Overdose Nov/8/2020 00:
43 NO
End Date Time:
Nov/8/2020 UNK:UNK
Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044153
Page 75 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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)[CARDIAC ARREST]
4.Start Date Time: Nov/8/2020 00:43
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/8/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.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:
[possible intentional overdose, or. poor choice of alcohol and drug abuse.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044154
Page 76 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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[2020443745]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044155
Page 77 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Respiratory Failure]
4.Start Date Time: Nov/8/2020 00:43
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.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:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044156
Page 78 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020443745]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044157
Page 79 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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)[Overdose]
4.Start Date Time: Nov/8/2020 00:43
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/8/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.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:
[multi-drug ingestion]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044158
Page 80 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[2020443745]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044159
Page 81 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044160
Page 82 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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[ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044161
Page 83 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044162
Page 84 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044163
Page 85 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044164
Page 86 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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?
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044165
FDA-CBER-2021-5683-0044166
Page 88 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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?
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044167
FDA-CBER-2021-5683-0044168
Page 90 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044169
Page 91 of 334
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044170
Page 92 of 334
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044171
Page 93 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044172
Page 94 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044173
Page 95 of 334
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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?
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044174
Page 96 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044175
Page 97 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044176
Page 98 of 334
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044177
Page 99 of 334
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044178
Page 100 of 334
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044179
Page 101 of 334
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044180
Page 102 of 334
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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 :Dec/14/2020
2.Phase of Disposition: VACCINATION
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [SUBJECT IS LOST TO FOLLOW UP]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044181
Page 103 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit Not Applicable Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044182
Page 104 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044183
Page 105 of 334
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/14/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [LOST TO FOLLOW UP]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044184
Page 106 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044185
Page 107 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044186
Page 108 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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: [ ]
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044187
Page 109 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/14/2020
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044188
Page 110 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044189
Page 111 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Name Signature
MeaningDate Type Action
Matthew Davis Approved Mar-12-2021 13:19:54 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044190
Page 112 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-19-2020 10:58:37 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044191
Page 113 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-10-2021 15:24:58 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044192
Page 114 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-10-2021 15:24:58 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044193
Page 115 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-10-2021 15:24:58 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044194
Page 116 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-10-2021 15:25:14 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044195
Page 117 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-10-2021 15:25:14 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044196
Page 118 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aMar-10-2021 15:25:14 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044197
Page 119 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aMar-10-2021 15:25:14 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044198
Page 120 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aMar-10-2021 15:25:14 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044199
Page 121 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-10-2021 15:25:30 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044200
Page 122 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-10-2021 15:25:30 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044201
Page 123 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-10-2021 15:25:30 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044202
Page 124 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-10-2021 15:25:30 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044203
Page 125 of 334
***Confidential***
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Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Mar-10-2021 15:25:30 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044204
Page 126 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044205
Page 127 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044206
Page 128 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044207
Page 129 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044208
Page 130 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044209
Page 131 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044210
Page 132 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044211
Page 133 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044212
Page 134 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044213
Page 135 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044214
Page 136 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
10Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044215
Page 137 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
11Mar-10-2021 15:25:46 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Done
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044216
Page 138 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Dec-05-2020 08:02:32 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
2Nov-30-2020 13:16:37 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)
2Nov-24-2020 15:12:26 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044217
Page 139 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Dec-05-2020 08:03:12 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
3Nov-30-2020 13:16:58 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)
3Nov-24-2020 15:12:37 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044218
Page 140 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.aJan-06-2021 14:40:46 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.aNov-24-2020 15:13:42 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.aNov-16-2020 15:16:48 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044219
Page 141 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.bJan-06-2021 14:41:46 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.bNov-24-2020 15:14:00 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.bNov-16-2020 15:16:56 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044220
Page 142 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.cJan-06-2021 14:42:03 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.cNov-24-2020 15:14:14 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.cNov-16-2020 15:17:07 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044221
Page 143 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.dJan-06-2021 14:42:17 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.dNov-24-2020 15:14:29 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.dNov-16-2020 15:17:15 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044222
Page 144 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.eJan-06-2021 14:42:30 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.eNov-24-2020 15:14:43 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.eNov-16-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044223
Page 145 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.fJan-06-2021 14:42:44 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.fNov-24-2020 15:15:00 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.fNov-16-2020 15:17:34 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044224
Page 146 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.gJan-06-2021 14:43:10 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.gNov-24-2020 15:15:19 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.gNov-16-2020 15:17:43 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044225
Page 147 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.hJan-06-2021 14:43:26 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.hNov-24-2020 15:15:33 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.hNov-16-2020 15:17:52 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044226
Page 148 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4.iJan-06-2021 14:43:47 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)
4.iNov-24-2020 15:15:49 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
4.iNov-16-2020 15:18:01 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044227
Page 149 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormFeb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044228
Page 150 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Feb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044229
Page 151 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aFeb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044230
Page 152 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aFeb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044231
Page 153 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aFeb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044232
Page 154 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aFeb-25-2021 08:26:53 (UTC-05:00) Eastern Time
(US & Canada)Julie Mooney
(pfe.jmooney)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044233
Page 155 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Nov-16-2020 15:32:08 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Unknown
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044234
Page 156 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-12-2021 11:21:40 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044235
Page 157 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-12-2021 11:21:40 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044236
Page 158 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-12-2021 11:21:40 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044237
Page 159 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-12-2021 11:21:55 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044238
Page 160 of 334
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-12-2021 11:21:55 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044239
Page 161 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-12-2021 11:21:13 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044240
Page 162 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-12-2021 11:21:13 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044241
Page 163 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-12-2021 11:21:13 (UTC-05:00) Eastern Time
(US & Canada)Jessica Fisher
(pfe.jfisher)Not Applicable
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044242
Page 164 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Name Signature
MeaningDate Type Action
Matthew Davis Approved Mar-12-2021 13:19:54 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Julie Mooney N/A Feb-16-2021 12:43:41 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Jan-25-2021 08:48:16 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Julie Mooney N/A Jan-22-2021 12:55:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Jan-20-2021 09:31:40 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044243
Page 165 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Julie Mooney N/A Jan-06-2021 14:40:46 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Jan-05-2021 12:50:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Chelsey
LoMonaco N/A Dec-28-2020 14:15:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Dec-09-2020 08:25:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044244
Page 166 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Julie Mooney N/A Dec-05-2020 08:02:18 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Dec-02-2020 08:47:46 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Chelsey
LoMonaco N/A Nov-30-2020 13:16:37 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Nov-25-2020 09:03:13 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Julie Mooney N/A Nov-23-2020 13:36:24 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Nov-17-2020 17:44:49 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044245
Page 167 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044246
Page 168 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Oct-19-2020 10:50:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020 10:50:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044247
Page 169 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Oct-19-2020 10:50:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/19/2020Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044248
Page 170 of 334
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Oct-19-2020 10:50:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10051293Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 10:50:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 10:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 10:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020 10:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044249
Page 171 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 10:57:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/19/2020Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044250
Page 172 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020 10:58:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 10:58:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 10:58:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044251
Page 173 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:OSTEOARTHRI
TIS
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020 10:59:09
(UTC-05:00) Eastern 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
Oct-19-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OSTEOARTHRITISInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020 10:59:35
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num 2Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044252
Page 174 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) ber:
Medical Histor
y Term:Gastroesophageal ref
lux disease
Start Date: UNK/UNK/2018
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020 10:59:35
(UTC-05:00) Eastern 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
Oct-19-2020 10:59:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 10:59:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020 10:59:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020 10:59:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:HIGH CHOLEST
EROL
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044253
Page 175 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 10:59:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 10:59:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HIGH CHOLESTEROLInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 10:59:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 10:59:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020 11:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:VASECTOMY
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2
005Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044254
Page 176 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020 11:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 11:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VASECTOMYInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020 11:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020 11:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.e
Date Location User Value Reason
Oct-19-2020 11:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:CERVICAL FUS
ION
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/20
13Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044255
Page 177 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020 11:00:40
(UTC-05:00) Eastern 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
Oct-19-2020 11:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CERVICAL FUSIONInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020 11:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020 11:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.f
Date Location User Value Reason
Oct-19-2020 11:01:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:RIGHT INGUINAL H
ERNIA REPAIR
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044256
Page 178 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020 11:01:01
(UTC-05:00) Eastern 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
Oct-19-2020 11:01:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHT INGUINAL HERNIA REP
AIRInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020 11:01:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020 11:01:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.g
Date Location User Value Reason
Dec-07-2020 10:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Alcohol Use Dis
order
Start Date: UNK/UNK/1973
Ongoing: YESInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044257
Page 179 of 334
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g Line/MH Number:
Date Location User Value Reason
Dec-07-2020 10:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 10:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Alcohol Use DisorderInitial Entry
1.g Start Date:
Date Location User Value Reason
Dec-07-2020 10:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/1973Initial Entry
1.g Ongoing:
Date Location User Value Reason
Dec-07-2020 10:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YESInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044258
Page 180 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020 11:01:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044259
Page 181 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
206.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
72.3Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.8Initial Entry
7.a
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044260
Page 182 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier:: 1
Temperature: 96.7
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020 11:33:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Mathias
(pfe mathij15)Query 1: Closed Response satisfies
query
Oct-19-2020 11:03:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered NCS PER PI
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.7 F is
outside of Normal
Range 97 - 99.5 F.
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
96.7Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-19-2020 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044261
Page 183 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020 11:02:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020 11:02:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
270739Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044262
Page 184 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 12:03:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 12:03:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 12:03:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 12:03:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-19-2020 12:03:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 12:03:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W8KInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044263
Page 185 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-19-2020 12:03:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W8KInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 12:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W8LInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 12:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W8LInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 12:03:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB06JInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 12:03:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPB06JInitial Entry
5.d
Date Location User Value Reason
Oct-20-2020 10:25:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB06KTranscription Error
Oct-19-2020 12:03:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB06LInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044264
Page 186 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Oct-20-2020
15:34:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Cl
osedAuto closed by
Validation Check:
VC_BEETRK001_01
Oct-20-2020
10:25:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredTranscription Error
Oct-20-2020
10:25:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data Entry
:
BPB06KTranscription Error
Oct-19-2020
16:19:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW5068779;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Oct-19-2020
12:03:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data Entry
:
BPB06LInitial Entry
5.e
Date Location User Value Reason
Oct-19-2020 12:03:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB06LInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044265
Page 187 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e Sample ID
Date Location User Value Reason
Oct-20-2020
15:34:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Cl
osedAuto closed by
Validation Check:
VC_BEETRK001_01
Oct-20-2020
10:25:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Query 1: An
sweredOriginal value is
correct
Oct-19-2020
16:19:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW5068780;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Oct-19-2020
12:03:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data Entry
:
BPB06LInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044266
Page 188 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 12:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 12:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 12:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 12:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB0J6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 12:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPB0J6Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044267
Page 189 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/19/2020 08:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044268
Page 190 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-19-2020 11:02:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044269
Page 191 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020 11:03:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044270
Page 192 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 15:24:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-10-2021 15:24:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044271
Page 193 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Mar-10-2021 15:25:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044272
Page 194 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 15:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 15:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 15:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-10-2021 15:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044273
Page 195 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Mar-12-2021
13:12:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query
1: Clo
sedResponse satisfies query
Mar-12-2021
11:20:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Query
1: Ans
weredPatient was lost to follow up
on 14Dec2021 after
hospitalization. Treatment
eCRF should not have to be
completed.
Mar-10-2021
23:50:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7668935;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044274
Page 196 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate.
Mar-10-2021
15:25:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044275
Page 197 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Mar-10-2021 15:25:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Not DoneInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044276
Page 198 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 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
Jan-06-2021 14:48:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Jan-05-2021 07:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Nov-17-2020 10:05:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jennifer
Mathias
(pfe mathij15)Query 1: Closed Response satisfies query
Nov-17-2020 08:43:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered Nasal Swab Self not
obtained at this time
Nov-17-2020 02:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swapna
Varikuti
(pfe.variks)Query 1: Opened PDQ : Details of Sample ID
and collection date for
either Nasal Swab Self or
Nasal Swab expected to be
completed. Please check
and update else clarify.
Nov-16-2020 15:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-16-2020 15:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is completed
but Date of Assessment in
the Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Nov-16-2020 15:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is completed
but Date of Collection in
both Nasal Swab Self and
Nasal Swab are missing.
Please review and update as
appropriate.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044277
Page 199 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-16-2020 15:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-16-2020 15:15:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044278
Page 200 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-07-2021 02:20:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Closed clinical query already
for clarifying
shortness of breath
Jan-06-2021 14:44:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered Original value is
correct
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there is
no Other Symptom
reported. Please
review and update as
appropriate.
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-08-2021 12:14:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Vrunda Parikh
(pfe.parikv06)Query 2: Closed Response satisfies
query
Jan-06-2021 14:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 2: Answered PER CRA ANSWER
EACH
PRE-DEFINED
SYMPTOMS
SHOULD BE NO
Dec-08-2020 14:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Vrunda Parikh
(pfe.parikv06)Query 2: Reissued:Opened CLINQUERY: Please
follow up with CRA.
Inquire/Obtain
information regarding
ANY subject
symptoms during
episode of ACUTE
RESPIRATORY
FAILURE (e.g.
Shortness of breath,
etc.) and update CRF.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044279
Page 201 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-05-2020 08:02:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Dec-05-2020 08:02:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Dec-05-2020 08:02:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Dec-03-2020 08:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Vrunda Parikh
(pfe.parikv06)Query 2: Reissued:Opened CLINQUERY:
Symptoms Start date
of 08NOV2020 is
provided. What
symptom was this?
Please inquire with
subject or from source
regarding ANY
subject symptoms
during episode of
ACUTE
RESPIRATORY
FAILURE (e.g.
Shortness of breath,
etc.) and update CRF.
Dec-01-2020 07:17:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 2: Answered Symptoms reported
were unknown - covid
illness visit completed
off of medical records
per sponsor request
Nov-30-2020 16:20:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Vrunda Parikh
(pfe.parikv06)Query 2: Opened CLINQUERY: Per
CCG 8.30, enter all
symptoms that occur
during the course of
the illness (even if
they are not present
during the illness
visit). Please
enter/update this CRF
to reflect all the
symptoms that the
participant reported
throughout the illness
Nov-30-2020 13:17:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/8/2020Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044280
Page 202 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-30-2020 13:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry: Initial Entry
Nov-25-2020 01:52:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Closed Response satisfies
query
Nov-25-2020 01:43:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Reissued:Opened DM1: Please verify
patient details and
update when subject is
having first sign and
symptoms of Covid
ILL due to which
assessment has been
done. Thank you.
Nov-24-2020 15:12:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-24-2020 06:57:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered unknown
Nov-24-2020 06:57:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: unknown
Nov-24-2020 06:43:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Divya M
(pfe md09)Query 1: Opened DM: Since all the
symptoms are marked
as Unknown, please
review and clarify the
date of first symptom
reported. Please
update data as
appropriate.
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/8/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-05-2020 08:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Dec-05-2020 08:03:02
(UTC-05:00) EasternACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044281
Page 203 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
Nov-30-2020 15:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 2: Closed Response satisfies
query
Nov-30-2020 13:17:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Nov-30-2020 13:17:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
Nov-30-2020 13:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry: Initial Entry
Nov-26-2020 07:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Reissued:Opened DM: Please review
and update
Symptoms Ongoing
at item #3 with the
help of CRA. Thank
you.
Nov-25-2020 16:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 2: Answered No is not an option
only Not Done, N/A,
or Unknown
Nov-25-2020 01:54:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Closed Response satisfies
query
Nov-25-2020 01:53:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 2: Opened DM: Please update
Symptom Present =
NO instead not
applicable for all
symptoms field on
this form. Thank you.
Nov-24-2020 15:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered Changed data per
query
Nov-24-2020 15:12:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-24-2020 07:48:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 1: Reissued:Opened Form should be
completed for
subjects who
experience
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044282
Page 204 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
symptoms. If no
symptoms
experienced, then
Date of Assessment
should be entered,
Date of First
Symptom Started =
Not Applicable,
Symptom Ongoing?
= Not Applicable &
Symptom Present =
NO for all symptoms
Nov-23-2020 13:36:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered unknown
Nov-23-2020 13:36:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: unknown
Nov-22-2020 23:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Reissued:Opened DM : Symptoms
ongoing is recorded
as YES. However,
Symptom present are
recorded as
unknown. Please
review and update.
Else, clarify.
Nov-19-2020 08:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered COVID illness visit
completed off of
hospital medical
records - no
symptoms listed on
medical records -
covid visit completed
per sponsor request
Nov-18-2020 00:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Vikas Joshi
(pfe.joshiv22)Query 1: Reissued:Opened DM: Per CRF
completion
guidelines section
8.30.5., If the
symptoms were
present AT ANY
TIME during the
Potential COVID-19
Illness, please
enter/update this
CRF to reflect all the
symptoms that the
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044283
Page 205 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
participant reported
throughout the
Illness.
Nov-17-2020 08:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered correct as is
Nov-17-2020 07:29:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nishanthi
Audhimoolam
(pfe.audhin)Query 1: Opened DM Query:
Symptoms present
are Unknown. Please
review and update
the data as
appropriate. Thank
you.
Nov-16-2020 15:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-06-2021 14:40:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
Jan-06-2021 14:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: FEVER
Symptom Present:Initial Entry
Nov-24-2020 15:13:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: FEVER
Symptom Present: Not ApplicableInitial Entry
Nov-16-2020 15:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: FEVER
Symptom Present: UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: FEVER
Symptom Present:Initial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044284
Page 206 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)LoMonaco
(pfe.clomonaco)FEVER
4.a Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:40:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:13:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.b
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
Jan-06-2021 14:41:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:Initial Entry
Nov-24-2020 15:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:Not ApplicableInitial Entry
Nov-16-2020 15:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:UnknownInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044285
Page 207 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:Initial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:41:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:14:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.c
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:NOInitial Entry
Jan-06-2021 14:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
THInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044286
Page 208 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sympto
m Presen
t:
Nov-24-2020 15:14:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:Not ApplicableInitial Entry
Nov-16-2020 15:17:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044287
Page 209 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.c Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED SHORTNE
SS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:14:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.d
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
Jan-06-2021 14:42:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: CHILLS
Symptom Present:Initial Entry
Nov-24-2020 15:14:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: CHILLS
Symptom Present: Not ApplicableInitial Entry
Nov-16-2020 15:17:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: CHILLS
Symptom Present: UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
Symptoms: CHILLSInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044288
Page 210 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe.clomonaco) Symptom Present:
4.d Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:42:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:14:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.e
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
Jan-06-2021 14:42:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:Initial Entry
Nov-24-2020 15:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAINInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044289
Page 211 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptom
Present:Not Applicable
Nov-16-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:Initial Entry
4.e Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:42:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044290
Page 212 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
4.f
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
Jan-06-2021 14:42:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:Initial Entry
Nov-24-2020 15:15:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:Not ApplicableInitial Entry
Nov-16-2020 15:17:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044291
Page 213 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.f Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:42:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:15:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.g
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
Jan-06-2021 14:43:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:Initial Entry
Nov-24-2020 15:15:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:Not ApplicableInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044292
Page 214 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-16-2020 15:17:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:Initial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:43:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:15:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.h
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
Jan-06-2021 14:43:26
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044293
Page 215 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) Symptoms: DIARRHEA
Symptom Present:
Nov-24-2020 15:15:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: DIARRHEA
Symptom Present
:Not Applicabl
eInitial Entry
Nov-16-2020 15:17:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: DIARRHEA
Symptom Present: UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: DIARRHEA
Symptom Present:Initial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:43:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:15:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:17:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
4.i
Date Location User Value Reason
Jan-06-2021 14:44:02 ACV0PFEINFP6000 Julie Mooney Data Entry: Initial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044294
Page 216 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)(pfe.jmooney) Symptoms: VOMITING
Symptom Present: NO
Jan-06-2021 14:43:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: VOMITING
Symptom Present:Initial Entry
Nov-24-2020 15:15:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Symptoms: VOMITING
Symptom Present
:Not Applicabl
eInitial Entry
Nov-16-2020 15:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: VOMITING
Symptom Present: UnknownInitial Entry
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: VOMITING
Symptom Present:Initial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-16-2020 15:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-06-2021 14:44:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOInitial Entry
Jan-06-2021 14:43:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Initial Entry
Nov-24-2020 15:15:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 15:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UnknownInitial Entry
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044295
Page 217 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044296
Page 218 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/8/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-23-2020 17:34:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
SWABBED MATERIALNew Information
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RESPIRATORY SECRETIONSInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-17-2020 10:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jennifer
Mathias
(pfe.mathij15)Query 1: Closed Response satisfies
query
Nov-17-2020 08:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered specimen collection
location unknown per
source
Nov-17-2020 08:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jennifer
Mathias
(pfe.mathij15)Query 1: Opened Per eCRF completion
guidelines, if
Respiratory Secretions
are indicated as the
Specimen Type, please
select LOWER
RESPIRATORY
SYSTEM. Otherwise,
please indicate the site
of the Swab as
NASOPHARYNX or
THROAT.
Nov-16-2020 15:19:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044297
Page 219 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051293 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-16-2020 15:19:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-24-2020 00:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Nov-23-2020 17:33:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-23-2020 17:33:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NEGATIVENew Information
Nov-20-2020 02:18:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Reissued:Opened DM: Please let us
know when you will
be able to update test
results. Thank you.
Nov-19-2020 08:18:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered results are still
unknown at this time
Nov-18-2020 05:00:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: The response
for "Test Results" is
missing. Kindly
review and update.
090177e196ae2f6d\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-56
…[truncated]