125742 S1 M5 CRF c4591001 1005 10051387

Document text

Page 1 of 202
***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: 10051387 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
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044594
Page 2 of 202
***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: 10051387 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/29/2020
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044595
Page 3 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051387]
2.Birth Date: /1964
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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044596
Page 4 of 202
***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: 10051387 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/29/2020
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044597
Page 5 of 202
***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: 10051387 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
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044598
Page 6 of 202
***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: 10051387 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/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044599
Page 7 of 202
***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: 10051387 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:[ASTHMA]
Start Date: UNK/UNK/1994
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ENVIRONMENTAL ALLERGIES]
Start Date: UNK/UNK/1994
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OVERWEIGHT]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIGH BLOOD PRESSURE]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044600
Page 8 of 202
***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: 10051387 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:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1997
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MENOPAUSE]
Start Date: UNK/UNK/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROID]
Start Date: UNK/UNK/2010
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT FOREARM MELANOMA]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044601
Page 9 of 202
***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: 10051387 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:[RIGHT OOPHORECTOMY]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MELANOMA REMOVAL FROM RIGHT FOREARM]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NISSAN FUNDOPLICATION]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044602
Page 10 of 202
***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: 10051387 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
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044603
Page 11 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
2.Weight: [225.0]
3.Unit: LB
4.Height: [69.5]
5.Unit: in
6.Body Mass Index: [32.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044604
Page 12 of 202
***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: 10051387 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/29/2020
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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044605
Page 13 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/29/2020
2.Randomization Number: [273643]
3.Randomization Group: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044606
Page 14 of 202
***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: 10051387 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/29/2020
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 [BPTZ99]
5.bSample ID [BPTZ9B]
5.cSample ID [BPTZ9C]
5.dSample ID [BJ3WMP]
5.eSample ID [BJ3WMR]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044607
Page 15 of 202
***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: 10051387 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/29/2020
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 [BPTZ6X]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044608
Page 16 of 202
***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: 10051387 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/29/2020 09:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044609
Page 17 of 202
***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: 10051387 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
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044610
Page 18 of 202
***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: 10051387 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/17/2020
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044611
Page 19 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044612
Page 20 of 202
***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: 10051387 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/17/2020
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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044613
Page 21 of 202
***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: 10051387 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/17/2020
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 [BM8R4Z]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044614
Page 22 of 202
***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: 10051387 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/17/2020 08:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044615
Page 23 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044616
Page 24 of 202
***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: 10051387 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/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGWG5]
5.bSample ID [BRGWG6]
5.cSample ID [BRGWG7]
5.dSample ID [BSMXJS]
5.eSample ID [BSMXJT]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044617
Page 25 of 202
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044618
Page 26 of 202
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044619
Page 27 of 202
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044620
Page 28 of 202
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044621
Page 29 of 202
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044622
Page 30 of 202
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044623
Page 31 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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/23/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044624
Page 32 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/23/2021
2.Date of First Symptom Started: Jan/22/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/30/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044625
Page 33 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044626
Page 34 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/22/20
21 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044627
Page 35 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/22/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044628
Page 36 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
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 [CV56531]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044629
Page 37 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: 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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[NOT NEEDED PER PI]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044630
Page 38 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044631
Page 39 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044632
Page 40 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044633
Page 41 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044634
Page 42 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Bronchitis]
Date of Diagnosis:
Jan/26/2021
3.Toxicity Grade: 1
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044635
Page 43 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044636
Page 44 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044637
Page 45 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044638
Page 46 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044639
Page 47 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044640
Page 48 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044641
FDA-CBER-2021-5683-0044642
Page 50 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044643
FDA-CBER-2021-5683-0044644
Page 52 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044645
FDA-CBER-2021-5683-0044646
Page 54 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044647
Page 55 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044648
Page 56 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044649
FDA-CBER-2021-5683-0044650
Page 58 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/22/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044651
Page 59 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10051387 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/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044652
Page 60 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: 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: 10051387 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:
Feb/24/2021
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 [BRN051]
5.bSample ID [BRN052]
5.cSample ID [BRN05W]
5.dSample ID [BSC2P5]
5.eSample ID [BSC2P6]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044653
Page 61 of 202
***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: 10051387 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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044654
Page 62 of 202
***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: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044655
Page 63 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  INJECTION SITE PAIN  Oct/30/2020 U
NK:UNK NO
End Date Time:
Oct/31/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  MYALGIA  Nov/17/2020 2
0:30 NO
End Date Time:
Nov/18/2020 08:30
 Repeating
Pages
 3.ADVERSE
EVENT 3  SWOLLEN LYMPH NODE
UNDER LEFT ARM Nov/18/2020 2
1:00 NO
End Date Time:
Dec/19/2020 UNK:
UNK
 Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044656
Page 64 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/31/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044657
Page 65 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044658
Page 66 of 202
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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)[MYALGIA]
4.Start Date Time: Nov/17/2020 20:30
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/18/2020 08:30
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044659
Page 67 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044660
Page 68 of 202
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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)[SWOLLEN LYMPH NODE UNDER LEFT ARM]
4.Start Date Time: Nov/18/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044661
Page 69 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044662
Page 70 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044663
Page 71 of 202
***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: 10051387 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[ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044664
Page 72 of 202
***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: 10051387 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
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044665
Page 73 of 202
***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: 10051387 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: //
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044666
Page 74 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044667
Page 75 of 202
***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: 10051387 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?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044668
Page 76 of 202
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044669
Page 77 of 202
***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: 10051387 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?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044670
FDA-CBER-2021-5683-0044671
Page 79 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044672
Page 80 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044673
Page 81 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044674
Page 82 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044675
Page 83 of 202
***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: 10051387 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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044676
Page 84 of 202
***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: 10051387 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:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044677
Page 85 of 202
***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: 10051387 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?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044678
Page 86 of 202
***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: 10051387 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: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044679
Page 87 of 202
***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: 10051387 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: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044680
Page 88 of 202
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044681
Page 89 of 202
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044682
Page 90 of 202
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044683
Page 91 of 202
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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 [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044684
Page 92 of 202
***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: 10051387 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044685
Page 93 of 202
***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: 10051387 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
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044686
Page 94 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044687
Page 95 of 202
***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: 10051387 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: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044688
Page 96 of 202
***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: 10051387 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/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044689
Page 97 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044690
Page 98 of 202
***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: 10051387 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: [ ]
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044691
Page 99 of 202
***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: 10051387 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/15/2020
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044692
Page 100 of 202
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Casebook Signature Form
1.Casebook Signature
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044693
Page 101 of 202
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044694
Page 102 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormOct-29-2020 10:24:58 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044695
Page 103 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044696
Page 104 of 202
***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: 10051387 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-29-2020 10:22:57
(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-29-2020 10:22:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044697
Page 105 of 202
***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: 10051387 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-29-2020 10:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/29/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044698
Page 106 of 202
***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: 10051387 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-29-2020 10:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10051387Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-29-2020 10:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-29-2020 10:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-29-2020 10:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-29-2020 10:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044699
Page 107 of 202
***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: 10051387 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-29-2020 10:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044700
Page 108 of 202
***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: 10051387 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-29-2020 10:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 10:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020 10:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044701
Page 109 of 202
***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: 10051387 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-29-2020 10:55:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ASTHMA
Start Date: UNK/UN
K/1994
Ongoing: YESTranscription
Error
Oct-29-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ASTHMA
Start Date: UNK/UN
K/2002
Ongoing: YESTranscription
Error
Oct-29-2020 10:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ASTHMA
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044702
Page 110 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 10:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ASTHMAInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-29-2020 10:55:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1994Transcription
Error
Oct-29-2020 10:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2002Transcription
Error
Oct-29-2020 10:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-29-2020 10:25:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-29-2020 13:53:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:ENVIRONME
NTAL ALLER
GIES
Start Date
:UNK/UNK/19
94
Ongoing: YESNew Information
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044703
Page 111 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-29-2020 10:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:EVIRONMEN
TAL ALLERG
IES
Start Date
:UNK/UNK/19
94
Ongoing: YESTranscription
Error
Oct-29-2020 10:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:EVIRONMEN
TAL ALLERG
IES
Start Date
:UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044704
Page 112 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:26:03
(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 ValueReason
Oct-29-2020
21:34:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy has
been closed.
Oct-29-2020
13:53:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dNew Information
Oct-29-2020
13:53:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data
Entry
:
ENVI
RON
MEN
TAL
ALLE
RGIE
SNew Information
Oct-29-2020
13:09:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedClarify
EVIRONMENTAL
ALLERGIES as
follows...Should
spelling be
ENVIRONMENTAL
ALLERGIES? If
so,edit. Otherwise,
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044705
Page 113 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
clarify. Thank you.
Oct-29-2020
10:26:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data
Entry
:
EVIR
ONM
ENTA
L AL
LER
GIESInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-29-2020 10:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1994Transcription
Error
Oct-29-2020 10:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-29-2020 10:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-29-2020 10:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:OVERWEI
GHT
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044706
Page 114 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:56:04
(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-29-2020 10:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OVERWEIGHTInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-29-2020 10:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-29-2020 10:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-29-2020 10:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:HIGH BLOOD
PRESSURE
Start Date: UNK/UNK/201
2
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044707
Page 115 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:56:17
(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-29-2020 10:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HIGH BLOOD PRESSUREInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-29-2020 10:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-29-2020 10:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-29-2020 10:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:Gastroesophagea
l reflux disease
Start Date: UNK/UNK/1997
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044708
Page 116 of 202
***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: 10051387 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-29-2020 10:56:49
(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-29-2020 10:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Gastroesophageal reflux dise
aseInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-29-2020 10:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1997Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-29-2020 10:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-29-2020 10:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:MENOPAU
SE
Start Date: UNK/UNK/
2017
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044709
Page 117 of 202
***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: 10051387 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-29-2020 10:57:00
(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-29-2020 10:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MENOPAUSEInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-29-2020 10:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-29-2020 10:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-30-2020 07:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:HYPOTH
YROID
Start Date: UNK/UN
K/2010
Ongoing: YESTranscription
Error
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044710
Page 118 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-29-2020 10:57:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:HYPOTH
RYOID
Start Date: UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044711
Page 119 of 202
***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: 10051387 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-29-2020 10:57:12
(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-30-2020
08:01:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1
: ClosedDiscrepancy has
been closed.
Oct-30-2020
07:03:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1
: Answe
redTranscription
Error
Oct-30-2020
07:03:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data E
ntry:
HYPOT
HYROI
DTranscription
Error
Oct-29-2020
15:30:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1
: Opene
dClarify
HYPOTHRYOID
as follows. Please
confirm if
spelling should be
HYPOTHYROID
and edit term. Or
further clarify and
edit. Thank you.
Oct-29-2020
10:57:12
(UTC-05:00)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data E
ntry:
HYPOTInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044712
Page 120 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Eastern Time
(US &
Canada)HRYOI
D
1.g Start Date:
Date Location User Value Reason
Oct-29-2020 10:57:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044713
Page 121 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.g Ongoing:
Date Location User Value Reason
Oct-29-2020 10:57:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-29-2020 10:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH
Number:8
Medical
History T
erm:RIGHT FOREA
RM MELANO
MA
Start Dat
e:UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/2
018New Information
Oct-29-2020 10:57:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:RIGHT FORE
ARM MELAN
OMA
Start Date
:UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044714
Page 122 of 202
***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: 10051387 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-29-2020 10:57:28
(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-29-2020 10:57:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHT FOREARM MELA
NOMAInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-29-2020 10:57:28
(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-29-2020 10:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2018New Information
Oct-29-2020 10:57:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-29-2020 10:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044715
Page 123 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Hist
ory Term:RIGHT OOPHO
RECTOMY
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2
006
1.i Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:57:44
(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-29-2020 10:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHT OOPHORECTOMYInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-29-2020 10:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2006Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-29-2020 10:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.j
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044716
Page 124 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-29-2020 10:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:10
Medical
History
Term:MELANOMA REM
OVAL FROM RIGH
T FOREARM
Start Da
te:UNK/UNK/2018
Ongoing
:NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044717
Page 125 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.j Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 10:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MELANOMA REMOVAL F
ROM RIGHT FOREARMInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-29-2020 10:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-29-2020 10:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.k
Date Location User Value Reason
Oct-29-2020 10:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:NISSAN FUND
OPLICATION
Start Date: UNK/UNK/1999Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044718
Page 126 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/19
99
1.k Line/MH Number:
Date Location User Value Reason
Oct-29-2020 10:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 10:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NISSAN FUNDOPLICATIO
NInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-29-2020 10:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1999Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-29-2020 10:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044719
Page 127 of 202
***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: 10051387 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-29-2020 10:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044720
Page 128 of 202
***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: 10051387 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-29-2020 10:32:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 10:32:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020Transcription
Error
Oct-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital Signs Date is
not the same as
Vaccination Date
in the same visit.
Please review and
update as
appropriate or
clarify.
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-29-2020 10:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
225.0New Information
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
183.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-29-2020 10:27:03
(UTC-05:00) EasternACV0PFEINFP6000  Chelsey
LoMonacoData Entry:
LBInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044721
Page 129 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
4. Height:
Date Location User Value Reason
Oct-29-2020 10:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
69.5Transcription
Error
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-29-2020 10:27:03
(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-29-2020 10:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.7Transcription Error
Oct-29-2020 10:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.2New Information
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.9Initial Entry
7.a
Date Location User Value Reason
Oct-29-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identif
ier::1Transcription
Error
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044722
Page 130 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Temperature: 97.1
Temperature
Unit:F
Temperature L
ocation::ORAL CA
VITY
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identif
ier::1
Temperature: 98.6
Temperature
Unit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-29-2020 10:27:03
(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-29-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.1Transcription
Error
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044723
Page 131 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7.a Temperature Location:
Date Location User Value Reason
Oct-29-2020 10:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044724
Page 132 of 202
***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: 10051387 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-29-2020 10:27:30
(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-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-29-2020 10:27:30
(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-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044725
Page 133 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Oct-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-29-2020 10:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044726
Page 134 of 202
***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: 10051387 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-29-2020 10:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-29-2020 10:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
273643Transcription
Error
Oct-29-2020 10:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
114465Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044727
Page 135 of 202
***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: 10051387 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-29-2020 10:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 10:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 10:28:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 10:28:22
(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-29-2020 10:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044728
Page 136 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-29-2020 10:28:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZ99Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 10:28:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZ99Initial Entry
5.b
Date Location User Value Reason
Oct-29-2020 10:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZ9BInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020 10:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZ9BInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020 10:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZ9CInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020 10:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZ9CInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044729
Page 137 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Oct-29-2020 10:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3WMPInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020 10:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3WMPInitial Entry
5.e
Date Location User Value Reason
Oct-29-2020 10:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3WMRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-29-2020 10:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3WMRInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044730
Page 138 of 202
***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: 10051387 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-29-2020 10:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 10:29:19
(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-29-2020 10:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 10:29:19
(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-29-2020 10:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044731
Page 139 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-29-2020 10:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BPTZ6XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 10:29:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BPTZ6XInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044732
Page 140 of 202
***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: 10051387 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-29-2020 10:30:07
(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-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020 10:30:07
(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-29-2020 10:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 10:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020 09:12Transcription
Error
Oct-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date,
29/Oct/2020 16:09
is a future date
relative to when it
was entered on
29/Oct/2020
10:30. Please
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044733
Page 141 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
correct.
Oct-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/29/2020 16:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020 10:30:07
(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-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020 10:30:07
(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-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-29-2020 10:30:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044734
Page 142 of 202
***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: 10051387 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-29-2020 10:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECTE
D FOR THIS SUBJECTInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044735
Page 143 of 202
***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: 10051387 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-17-2020 11:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/17/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044736
Page 144 of 202
***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: 10051387 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-17-2020 11:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/17/2020Initial Entry
2.a
Date Location User Value Reason
Nov-17-2020 11:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifi
er::1
Temperature: 97.7
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-17-2020 11:17:05
(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-17-2020 11:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044737
Page 145 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-17-2020 11:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-17-2020 11:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044738
Page 146 of 202
***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: 10051387 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-17-2020 11:17:13
(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-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-17-2020 11:17:13
(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-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044739
Page 147 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-17-2020 11:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044740
Page 148 of 202
***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: 10051387 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-17-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 11:17:37
(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-17-2020 11:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 11:17:37
(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-17-2020 11:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044741
Page 149 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-17-2020 11:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM8R4ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 11:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM8R4ZInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044742
Page 150 of 202
***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: 10051387 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-17-2020 11:18:20
(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-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-17-2020 11:18:20
(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-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/17/2020 08:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044743
Page 151 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Nov-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-17-2020 11:18:20
(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-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-17-2020 11:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044744
Page 152 of 202
***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: 10051387 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 12:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/15/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044745
Page 153 of 202
***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: 10051387 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-15-2020 12:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020 12:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-15-2020 12:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-15-2020 12:01:30
(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-15-2020 12:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044746
Page 154 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-15-2020 12:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRGWG5Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-15-2020 12:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRGWG5Initial Entry
5.b
Date Location User Value Reason
Dec-15-2020 12:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRGWG6Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-15-2020 12:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRGWG6Initial Entry
5.c
Date Location User Value Reason
Dec-15-2020 12:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRGWG7Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-15-2020 12:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRGWG7Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044747
Page 155 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Dec-15-2020 12:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXJSInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-15-2020 12:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXJSInitial Entry
5.e
Date Location User Value Reason
Dec-15-2020 12:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXJTInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-15-2020 12:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXJTInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044748
Page 156 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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-26-2021 14:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-26-2021 14:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-26-2021 14:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Jan-26-2021 14:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/23/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-26-2021 14:25:41
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044749
Page 157 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044750
Page 158 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/23/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/22/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-04-2021 14:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Fisher
(pfe.jfisher)Data Entry:
NO
Date of Last Symptom Res
olved:
Jan/30/2021New Information
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044751
Page 159 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044752
Page 160 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympt
oms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympt
om Pre
sent:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044753
Page 161 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.d Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044754
Page 162 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.f
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Presen
t:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044755
Page 163 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.g Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4.i
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044756
Page 164 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044757
Page 165 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044758
Page 166 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/22/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044759
Page 167 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-29-2021 11:46:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response
satisfies query
Jan-29-2021 11:41:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Jan-29-2021 11:41:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Julie Mooney
(pfe.jmooney)Data Entry:
NEGATIVEInitial Entry
Jan-29-2021 05:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Vikas Joshi
(pfe.joshiv22)Query 1: Opened DM: Please
complete this
item or let us
know the
tentative date by
when data is
expected. Thank
you
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-29-2021 11:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Julie Mooney
(pfe.jmooney)Data Entry: New Information
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RESULTS PENDINGInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044760
Page 168 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-26-2021 14:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NALT UNKNOWNInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044761
Page 169 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 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-26-2021 14:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 14:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021 14:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 14:27:32
(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-26-2021 14:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044762
Page 170 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-26-2021 14:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: CV56531Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-26-2021 14:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CV56531Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044763
Page 171 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: 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: 10051387 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-26-2021 14:28:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 14:28:13
(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-26-2021 14:28:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-26-2021 14:28:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT NEEDED PER PIInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044764
Page 172 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Practit
ioner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044765
Page 173 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Mar-04-2021 14:45:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Fisher
(pfe.jfisher)Data Entry:
Type of Pra
ctitioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence
of Visits or
Contacts:YES
Number of
Visits or Co
ntacts:
1Transcription
Error
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044766
Page 174 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-04-2021 14:45:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Fisher
(pfe.jfisher)Data Entry:
YES
Number of Visits or Conta
cts:
1Transcription
Error
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Prac
titioner:URGENT C
ARE
Occurrence
of Visits or C
ontacts:YES
Number of V
isits or Cont
acts:
1Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044767
Page 175 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Number of Visits or Contac
ts:
1Initial Entry
1.e
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044768
Page 176 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
TELEPHONE CONSULTAT
IONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044769
Page 177 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-26-2021 14:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044770
Page 178 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-26-2021 14:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-04-2021 15:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Fisher
(pfe.jfisher)Data Entry:
YES
Respiratory Illness Diagno
sis:
Bronchitis
Date of Diagnosis:
Jan/26/2021New Information
Jan-26-2021 14:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Respiratory Illness Diagno
sis:
ASTHMA FLARE
Date of Diagnosis:
Jan/22/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-26-2021 14:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044771
Page 179 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: IMAGING - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-26-2021 09:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Form Created
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044772
Page 180 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/23/2021Form: IMAGING - 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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-26-2021 09:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Jan/22/2021Initial Entry
2. Location of Assessment:
Date Location User Value Reason
Feb-26-2021 09:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
CHESTInitial Entry
3. Type of Imaging Exam:
Date Location User Value Reason
Feb-26-2021 09:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
X-RAYInitial Entry
4. Assessment:
Date Location User Value Reason
Feb-26-2021 09:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
NORMALInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044773
Page 181 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - 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: 10051387 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-24-2021 09:34:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Feb/24/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-24-2021 09:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
COVID_A1Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044774
Page 182 of 202
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: 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: 10051387 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
Feb-24-2021 09:34:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 09:34:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021 09:35:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 09:34:40
(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.
Feb-24-2021 09:34:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044775
Page 183 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: 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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-24-2021 09:35:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRN051Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021 09:35:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
BRN051Initial Entry
5.b
Date Location User Value Reason
Feb-24-2021 09:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRN052Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021 09:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
BRN052Initial Entry
5.c
Date Location User Value Reason
Feb-24-2021 09:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRN05WInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021 09:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
BRN05WInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044776
Page 184 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: 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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Feb-24-2021 09:35:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BSC2P5Initial Entry
5.d Sample ID
Date Location User Value Reason
Feb-24-2021 09:35:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
BSC2P5Initial Entry
5.e
Date Location User Value Reason
Feb-24-2021 09:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BSC2P6Initial Entry
5.e Sample ID
Date Location User Value Reason
Feb-24-2021 09:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
Fisher
(pfe.jfisher)Data Entry:
BSC2P6Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044777
Page 185 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044778
Page 186 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044779
Page 187 of 202
***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: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044780
Page 188 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/30/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Oct/31/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044781
Page 189 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044782
Page 190 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(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
Nov-17-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044783
Page 191 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MYALGIAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/17/2020 20:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Nov/18/2020 08:30Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044784
Page 192 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
6. Toxicity Grade:
Date Location User Value Reason
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044785
Page 193 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(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
Nov-24-2020 09:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044786
Page 194 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
SWOLLEN LYMPH NODE
UNDER LEFT ARMInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Nov/18/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-06-2021 11:51:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Teresa Vu
(pfe.vut11)Query 1: Closed Response satisfies
query
Jan-05-2021 07:11:04
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044787
Page 195 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
Jan-05-2021 07:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Dec/19/2020 UNK:UNKTranscription
Error
Jan-04-2021 10:52:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Teresa Vu
(pfe.vut11)Query 1: Opened 19Dec2020 per
source. Please
confirm and
update
accordingly.
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Nov/19/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(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.
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044788
Page 196 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(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
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044789
Page 197 of 202
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051387 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-15-2020 22:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044790
Page 198 of 202
***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: 10051387 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 12:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-15-2020 12:02:33
(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 12:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044791
Page 199 of 202
***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: 10051387 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-20-2021 10:08:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Liam
Sullivan
(pfe.lsullivan)Data Entry:
Dec/18/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044792
Page 200 of 202
***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: 10051387 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
Feb-02-2021 16:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Teresa Vu
(pfe.vut11)Query 1: Closed Response satisfies
query
Feb-01-2021 07:41:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-01-2021 07:41:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Participant is willing to retu
rn for Vaccination 3
Participant is:
eligible and NOT confir
med to have received onl
y placebo at Vaccination
1/2Transcription
Error
Jan-30-2021 23:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Teresa Vu
(pfe.vut11)Query 1: Opened Per source subject
is willing to return
for Vax3 and per
Form 1 subject
had Vaccine at V1
and V2. Therefore,
please confirm
this should be
"eligible and NOT
confirmed to have
received only
placebo at
Vaccination 1/2".
Jan-20-2021 10:08:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Liam Sullivan
(pfe.lsullivan)Data Entry:
Participant is NOT willing t
o return for Vaccination 3 O
R otherwise not eligibleInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044793
Page 201 of 202
***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: 10051387 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
Jan-20-2021 10:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Liam
Sullivan
(pfe.lsullivan)Data Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021 10:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Liam
Sullivan
(pfe.lsullivan)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044794
Page 202 of 202
***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: 10051387 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 12:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-29-2020 10:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-29-2020 10:25:10
(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 12:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/15/2020Initial Entry
Oct-29-2020 10:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Oct-29-2020 10:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
090177e196ae2f7c\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044795