Document text
Page 1 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044414
Page 2 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 10051347 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/22/2020
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044415
Page 3 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051347]
2.Birth Date: /1961
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044416
Page 4 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044417
Page 5 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044418
Page 6 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044419
Page 7 of 180
***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: 10051347 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:[ENVIRONMENTAL ALLERGIES]
Start Date: UNK/UNK/1970
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIGH BLOOD PRESSURE]
Start Date: UNK/UNK/1993
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MENOPAUSE]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BREAST LUMPECTOMY]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044420
Page 8 of 180
***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: 10051347 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:[CHOLECYSTECTOMY]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN BREAST FIBROIDS]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[UTERINE ABLATION]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GALLSTONES]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044421
Page 9 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DYSMENORRHEA]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044422
Page 10 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044423
Page 11 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
2.Weight: [156.8]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044424
Page 12 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044425
Page 13 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/22/2020
2.Randomization Number: [272165]
3.Randomization Group: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044426
Page 14 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTZ9Z]
5.bSample ID [BPTZB0]
5.cSample ID [BPTZB1]
5.dSample ID [BJ3W9R]
5.eSample ID [BJ3W9S]
5.fSample ID [BLGDN1]
5.gSample ID [BLGDN2]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044427
Page 15 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPB0HS]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044428
Page 16 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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/22/2020 08:59
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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044429
Page 17 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
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: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044430
Page 18 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
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: 10051347 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/12/2020
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044431
Page 19 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044432
Page 20 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044433
Page 21 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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:
Nov/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR62BW]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044434
Page 22 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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: Nov/12/2020 16:09
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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044435
Page 23 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044436
Page 24 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
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 [BR627R]
5.bSample ID [BR627S]
5.cSample ID [BR627T]
5.dSample ID [BSMXHC]
5.eSample ID [BSMXHD]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044437
Page 25 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044438
Page 26 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044439
Page 27 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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 [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044440
Page 28 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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 [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044441
Page 29 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044442
Page 30 of 180
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044443
Page 31 of 180
***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: 10051347 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:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044444
Page 32 of 180
***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: 10051347 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 [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044445
Page 33 of 180
***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: 10051347 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:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044446
Page 34 of 180
***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: 10051347 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 [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044447
Page 35 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 INJECTION SITE PAIN Jan/12/2021 U
NK:UNK NO
End Date Time:
Jan/13/2021 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 ENLARGED LYMPH NODE
LEFT AXILLA Jan/12/2021 U
NK:UNK NO
End Date Time:
Jan/26/2021 UNK:U
NK
Repeating
Pages
3.ADVERSE E
VENT 3 CHILLS Jan/12/2021 02:
00 NO
End Date Time:
Jan/12/2021 04:00
Repeating
Pages
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044448
Page 36 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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)[INJECTION SITE PAIN]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/13/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044449
Page 37 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044450
Page 38 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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)[ENLARGED LYMPH NODE LEFT AXILLA]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044451
Page 39 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044452
Page 40 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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)[CHILLS]
4.Start Date Time: Jan/12/2021 02:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/12/2021 04:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044453
Page 41 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044454
Page 42 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044455
Page 43 of 180
***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: 10051347 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[ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044456
Page 44 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044457
Page 45 of 180
***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: 10051347 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: //
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044458
Page 46 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044459
Page 47 of 180
***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: 10051347 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?
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044460
FDA-CBER-2021-5683-0044461
Page 49 of 180
***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: 10051347 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?
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044462
FDA-CBER-2021-5683-0044463
Page 51 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044464
Page 52 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044465
Page 53 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044466
Page 54 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044467
Page 55 of 180
***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: 10051347 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:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044468
Page 56 of 180
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044469
Page 57 of 180
***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: 10051347 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?
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044470
Page 58 of 180
***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: 10051347 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: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044471
Page 59 of 180
***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: 10051347 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: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044472
Page 60 of 180
***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: 10051347 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/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044473
Page 61 of 180
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044474
Page 62 of 180
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044475
Page 63 of 180
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044476
Page 64 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044477
Page 65 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044478
Page 66 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044479
Page 67 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044480
Page 68 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044481
Page 69 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS32SZ]
5.bSample ID [BS32T0]
5.cSample ID [BRL2JT]
5.dSample ID [BRL2JV]
5.eSample ID [BRL2JW]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044482
Page 70 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGWFL]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044483
Page 71 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 08:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044484
Page 72 of 180
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044485
Page 73 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044486
Page 74 of 180
***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: 10051347 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: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044487
Page 75 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044488
Page 76 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/11/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044489
Page 77 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF7Z7]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044490
Page 78 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/11/2021 15:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044491
Page 79 of 180
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044492
Page 80 of 180
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/8/2021
3.Comments: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044493
Page 81 of 180
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044494
Page 82 of 180
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044495
Page 83 of 180
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044496
Page 84 of 180
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044497
Page 85 of 180
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044498
Page 86 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044499
Page 87 of 180
***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: 10051347 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
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044500
Page 88 of 180
***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: 10051347 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 13:43:52 (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.
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044501
Page 89 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-22-2020 11:08:30 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044502
Page 90 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormDec-21-2020 13:42:35 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044503
Page 91 of 180
***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: 10051347 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 13:43:52 (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-08-2021 18:14:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Jan-21-2021 16:31:09 (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-21-2021 16:30:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044504
Page 92 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Matthew Davis Approved Jan-21-2021 16:27:36 (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.
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044505
Page 93 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:05:19
(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-22-2020 11:05:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044506
Page 94 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:05:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/22/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044507
Page 95 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:05:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10051347Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-22-2020 11:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-22-2020 11:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-22-2020 11:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-22-2020 11:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044508
Page 96 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044509
Page 97 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 11:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 11:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044510
Page 98 of 180
***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: 10051347 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-22-2020 11:11:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:ENVIRONMENT
AL ALLERGIES
Start Date: UNK/UNK/1970
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-22-2020 11:11:42
(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-22-2020 11:11:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ENVIRONMENTAL ALLERG
IESInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-22-2020 11:11:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1970Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-22-2020 11:11:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044511
Page 99 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b
Date Location User Value Reason
Oct-22-2020 11:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:HIGH BLOOD P
RESSURE
Start Date: UNK/UNK/1993
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-22-2020 11:11:57
(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-22-2020 11:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HIGH BLOOD PRESSUREInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-22-2020 11:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1993Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-22-2020 11:11:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044512
Page 100 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-22-2020 11:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:MENOPAUS
E
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-22-2020 11:13:22
(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-22-2020 11:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MENOPAUSEInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-22-2020 11:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-22-2020 11:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-22-2020 11:15:01
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 4Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044513
Page 101 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) mber:
Medical Histo
ry Term:BREAST LUMP
ECTOMY
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/19
93
1.d Line/MH Number:
Date Location User Value Reason
Oct-22-2020 11:15:01
(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-22-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BREAST LUMPECTOMYInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-22-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1993Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-22-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.e
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044514
Page 102 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-22-2020 11:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:CHOLECYSTE
CTOMY
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044515
Page 103 of 180
***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: 10051347 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-22-2020 11:15:33
(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-27-2020 20:46:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Oct-26-2020 10:32:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered ADDED
CONDITION PER
SOURCE
Oct-25-2020 21:39:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Opened ClinQuery:
cholecystectomy:
please also record
the condition/disease
that led to the
surgery/procedure
being required.
Please review and
update.
Oct-22-2020 11:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHOLECYSTECTOMYInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-22-2020 11:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-22-2020 11:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044516
Page 104 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
UNK/UNK/2018
1.f
Date Location User Value Reason
Oct-22-2020 11:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:BENIGN BREAST
FIBROIDS
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/199
3Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044517
Page 105 of 180
***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: 10051347 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-22-2020 11:17:17
(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-22-2020 11:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BENIGN BREAST FIBROIDSInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-22-2020 11:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1993Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-22-2020 11:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.g
Date Location User Value Reason
Oct-22-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:UTERINE ABL
ATION
Start Date: UNK/UNK/2008Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044518
Page 106 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/2
008
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044519
Page 107 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g Line/MH Number:
Date Location User Value Reason
Oct-22-2020 11:17:37
(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
Oct-26-2020 14:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter
(pfe.dychts)Query 1: Closed Response satisfies
query
Oct-26-2020 10:33:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered ADDED
CONDITION PER
SOURCE
Oct-24-2020 23:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Samuel Dychter
(pfe.dychts)Query 1: Opened GPD Clin: Please
add to the medical
history the
pathology that led
to the uterine
ablation therapy.
Oct-22-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UTERINE ABLATIONInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-22-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-22-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044520
Page 108 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.h
Date Location User Value Reason
Oct-26-2020 10:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:GALLSTONE
S
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044521
Page 109 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.h Line/MH Number:
Date Location User Value Reason
Oct-26-2020 10:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020 10:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
GALLSTONESInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-26-2020 10:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-26-2020 10:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.i
Date Location User Value Reason
Oct-26-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:DYSMENORR
HEA
Start Date: UNK/UNK/200
8Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044522
Page 110 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/
2008
1.i Line/MH Number:
Date Location User Value Reason
Oct-26-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DYSMENORRHEAInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-26-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2008Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044523
Page 111 of 180
***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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.i Ongoing:
Date Location User Value Reason
Oct-26-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044524
Page 112 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044525
Page 113 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
156.8Initial Entry
3. Unit:
Date Location User Value Reason
Oct-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-22-2020 11:19:31
(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-22-2020 11:19:31
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.8Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044526
Page 114 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier
::1
Temperature: 97.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-22-2020 11:19:31
(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-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-22-2020 11:19:31
(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-22-2020 11:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044527
Page 115 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044528
Page 116 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-22-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044529
Page 117 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-22-2020 11:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
272165Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044530
Page 118 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 11:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 11:24:44
(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-22-2020 11:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 11:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZ9ZInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044531
Page 119 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZ9ZInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 11:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZB0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZB0Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020 11:25:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZB1Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZB1Initial Entry
5.d
Date Location User Value Reason
Oct-22-2020 11:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W9RInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044532
Page 120 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W9RInitial Entry
5.e
Date Location User Value Reason
Oct-22-2020 11:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W9SInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W9SInitial Entry
5.f
Date Location User Value Reason
Oct-22-2020 11:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLGDN1Initial Entry
5.f Sample ID
Date Location User Value Reason
Oct-22-2020 11:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLGDN1Initial Entry
5.g
Date Location User Value Reason
Oct-22-2020 11:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLGDN2Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044533
Page 121 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.g Sample ID
Date Location User Value Reason
Oct-22-2020 11:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLGDN2Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044534
Page 122 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:26:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:26:48
(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-22-2020 11:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 11:26:48
(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-22-2020 11:26:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 11:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPB0HSInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044535
Page 123 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 11:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPB0HSInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044536
Page 124 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:20:21
(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-22-2020 11:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020 11:20:21
(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-22-2020 11:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/22/2020 08:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020 11:20:21
(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-22-2020 11:20:21
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
LEFTInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044537
Page 125 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
7. Route:
Date Location User Value Reason
Oct-22-2020 11:20:21
(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-22-2020 11:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-22-2020 11:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044538
Page 126 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-22-2020 11:21:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044539
Page 127 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Nov-13-2020 07:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/12/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044540
Page 128 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/12/2020Initial Entry
2.a
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier
::1
Temperature: 97.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044541
Page 129 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature Location:
Date Location User Value Reason
Nov-13-2020 07:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044542
Page 130 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044543
Page 131 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Nov-13-2020 07:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044544
Page 132 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Nov-13-2020 07:15:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 07:15:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 07:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 07:15:51
(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.
Nov-13-2020 07:15:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 07:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR62BWInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044545
Page 133 of 180
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 07:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR62BWInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044546
Page 134 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/12/2020 16:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
LEFTInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044547
Page 135 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
7. Route:
Date Location User Value Reason
Nov-13-2020 07:16:40
(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
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-13-2020 07:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044548
Page 136 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-15-2020 23:29:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Bhumika
Prabhu
(pfe.prabhb)Query 1: Closed Response satisfies
query
Dec-15-2020 07:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered completed
Dec-14-2020 04:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: The treatment
period is defined as
1st vaccination
visit through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF
and update date of
EOT to match date
of visit at visit 3.
Dec-11-2020 06:47:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/10/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044549
Page 137 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-11-2020 06:48:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-11-2020 06:48:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-11-2020 06:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-11-2020 06:48:18
(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.
Dec-11-2020 06:48:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-11-2020 06:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR627RInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044550
Page 138 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Dec-11-2020 06:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR627RInitial Entry
5.b
Date Location User Value Reason
Dec-11-2020 06:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR627SInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-11-2020 06:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR627SInitial Entry
5.c
Date Location User Value Reason
Dec-11-2020 06:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR627TInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-11-2020 06:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR627TInitial Entry
5.d
Date Location User Value Reason
Dec-11-2020 06:48:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXHCInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044551
Page 139 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Dec-11-2020 06:48:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXHCInitial Entry
5.e
Date Location User Value Reason
Dec-11-2020 06:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXHDInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-11-2020 06:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXHDInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044552
Page 140 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044553
Page 141 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044554
Page 142 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044555
Page 143 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
INJECTION SITE PAINInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/12/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Jan/13/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044556
Page 144 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 13:29:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Closed Response satisfies
query
Feb-25-2021 15:26:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Feb-25-2021 15:26:57 ACV0PFEINFP6000 Julie Mooney Data Entry: Transcription Error
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044557
Page 145 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)(pfe.jmooney) NOT APPLICABLE
Feb-18-2021 01:39:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sathenapalli
Suguna Srujan
(pfe.srujas)Query 2: Opened CLINQUERY:
Please review this
entry of 'Drug
Withdrawn' for this
event that occurred
after Vax 4. Since
subject has
completed the doses
on study, this entry
does not match with
status of subject.
Feb-17-2021 10:48:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Candidate CLINQUERY:
Please review this
entry of 'Drug
Withdrawn' for this
event that occurred
after Vax 4. Since
subject has
completed the doses
on study, this entry
does not match with
status of subject.
Feb-15-2021 09:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Feb-15-2021 06:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered please clarify as this
data is correct as
entered
Feb-12-2021 07:12:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened DM: "Latest action
taken with study
treatment" on AE
form is DRUG
WITHDRAWN but
AE Outcome is not
FATAL. Please
verify and update
the data as
appropriate else
clarify. Thank you.
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044558
Page 146 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044559
Page 147 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-17-2021 03:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Closed Response satisfies
query
Feb-16-2021 13:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-16-2021 13:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
ENLARGED LYMPH NODE
LEFT AXILLATranscription Error
Feb-14-2021 10:33:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPD Clin: Please
add to the AE term
the anatomical
area(s) where the
enlarged lymph
node occurred.
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ENLARGED LYMPH NODEInitial Entry
4. Start Date Time:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044560
Page 148 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/12/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Jan/26/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044561
Page 149 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 05:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044562
Page 150 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHILLSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/12/2021 02:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Jan/12/2021 04:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044563
Page 151 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044564
Page 152 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 05:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044565
Page 153 of 180
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 10051347 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
Dec-15-2020 07:30:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-15-2020 07:30:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-15-2020 07:30:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044566
Page 154 of 180
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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-21-2021 19:35:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Teresa Vu
(pfe.vut11)Query 1: Closed Response satisfies
query
Jan-21-2021 16:30:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-21-2021 16:30:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Dec/17/2020Transcription Error
Jan-21-2021 10:21:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sathenapalli
Suguna Srujan
(pfe.srujas)Query 1: Reissued:Opened Thanks for the
response, form has
been unfreeze,
please update as per
below query
Jan-21-2021 08:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered source provided -
please unfreeze this
form so date can be
updated.
Jan-19-2021 13:58:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Teresa Vu
(pfe.vut11)Query 1: Opened Please provide
source and confirm
contact date.
Dec-21-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/18/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044567
Page 155 of 180
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-21-2020 13:41:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044568
Page 156 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-21-2020 13:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-21-2020 13:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit is
before the Date
Written Consent
Obtained. Please
review and update
as appropriate.
Dec-21-2020 13:42:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/18/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044569
Page 157 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-21-2020 13:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-21-2020 13:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Dec/18/2020Transcription Error
Dec-21-2020 13:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained
is not the same as
the Date of Visit.
Please correct as
necessary.
Dec-21-2020 13:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Dec/21/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044570
Page 158 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-21-2020 13:43:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/18/2020Transcription Error
Dec-21-2020 13:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-21-2020 13:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-21-2020 13:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044571
Page 159 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044572
Page 160 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Dec-21-2020 13:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044573
Page 161 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-22-2020 09:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 09:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 09:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 09:42:25
(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.
Dec-22-2020 09:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 09:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BS32SZInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044574
Page 162 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 09:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BS32SZInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 09:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BS32T0Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-22-2020 09:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BS32T0Initial Entry
5.c
Date Location User Value Reason
Dec-22-2020 09:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2JTInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-22-2020 09:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2JTInitial Entry
5.d
Date Location User Value Reason
Dec-22-2020 09:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2JVInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044575
Page 163 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Dec-22-2020 09:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2JVInitial Entry
5.e
Date Location User Value Reason
Dec-22-2020 09:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2JWInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-22-2020 09:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2JWInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044576
Page 164 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-22-2020 09:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 09:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 09:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 09:43:43
(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.
Dec-22-2020 09:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 09:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRGWFLInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044577
Page 165 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 09:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRGWFLInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044578
Page 166 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/18/2020 08:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
LEFTInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044579
Page 167 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
7. Route:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-21-2020 13:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044580
Page 168 of 180
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-21-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-21-2020 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044581
Page 169 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Feb-17-2021
09:30:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Christian Mayfield
(pfe mayfic01)Query 1:
ClosedResponse
satisfies query
Feb-17-2021
07:49:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1:
Answere
dVisit OOW d/t
subject's
schedule. Per
PI, not IRB
reportable.
Feb-17-2021
01:21:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1:
OpenedPDQ: Date of
visit
V102_VAX4 is
out of window
for 1 days from
V101_VAX3
Dose Date.
Please verify
and update.
Else, confirm in
query response
appropriately.
"[lv04
SDQ=129170]"
Jan-12-2021
08:21:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data En
try:
Jan/11/2
021Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044582
Page 170 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/11/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044583
Page 171 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-12-2021 08:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044584
Page 172 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Jan-12-2021 08:22:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 08:22:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 08:22:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 08:22:06
(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.
Jan-12-2021 08:22:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021 08:22:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRF7Z7Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044585
Page 173 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 08:22:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRF7Z7Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044586
Page 174 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 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
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/11/2021 15:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
LEFTInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044587
Page 175 of 180
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
7. Route:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-12-2021 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044588
Page 176 of 180
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
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: 10051347 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
Feb-11-2021 14:40:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mina Francisco
(pfe.francm73)Query 1: Closed Response satisfies
query
Feb-11-2021 05:42:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered updated per request
Feb-09-2021 07:21:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Feb-08-2021 18:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Feb/8/2021Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044589
Page 177 of 180
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-08-2021 18:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-08-2021 18:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YES
Date of Contact:
Feb/8/2021Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044590
Page 178 of 180
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 10051347 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 ValueReason
Feb-12-2021
03:09:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pratiksha Mahadik
(pfe.mahadp07)Query
1: Clo
sedIncorrect Query
Feb-11-2021
09:57:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7232823;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-11-2021
05:42:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
Feb/8/
2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-11-2021 05:42:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-11-2021 05:42:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044591
Page 179 of 180
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - 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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-15-2020 07:30:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-22-2020 11:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-22-2020 11:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-15-2020 07:30:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-22-2020 11:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-22-2020 11:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044592
Page 180 of 180
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail 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: 10051347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-21-2021 10:43:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Liam
Sullivan
(pfe.lsullivan)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f6c\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0044593