125742 S1 M5 CRF c4591001 1008 10081603

Document text

Page 1 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133427
Page 2 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/14/2020
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133428
Page 3 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081603]
2.Birth Date: 1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133429
Page 4 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133430
Page 5 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133431
Page 6 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133432
Page 7 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sebaceous cyst of scalp]
Start Date: Sep/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes type II]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary artery disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133433
Page 8 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High cholesterol]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133434
Page 9 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133435
Page 10 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [202.6]
3.Unit: LB
4.Height: [68.5]
5.Unit: in
6.Body Mass Index: [30.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133436
Page 11 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [269278]
3.Randomization Group: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133437
Page 12 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGL5DZ]
5.bSample ID [BPCV02]
5.cSample ID [BPCV03]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133438
Page 13 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGL5BH]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133439
Page 14 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/14/2020 11:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133440
Page 15 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133441
Page 16 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133442
Page 17 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133443
Page 18 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BRGV1M]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133444
Page 19 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/5/2020 15:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133445
Page 20 of 173
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133446
Page 21 of 173
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
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 [BRD9J6]
5.bSample ID [BRT3NS]
5.cSample ID [BRT3NT]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133447
Page 22 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133448
Page 23 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133449
Page 24 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133450
Page 25 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133451
Page 26 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133452
Page 27 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133453
Page 28 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133454
Page 29 of 173
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133455
Page 30 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133456
Page 31 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133457
Page 32 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  SCALP ABCESS  Oct/26/2020 U
NK:UNK NO
End Date Time:
Oct/27/2020 UNK:
UNK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  SEPSIS  Oct/26/2020 U
NK:UNK NO
End Date Time:
Nov/2/2020 UNK:
UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  CELLULITIS UP
PER BACK Oct/26/2020 U
NK:UNK NO
End Date Time:
Nov/2/2020 UNK:
UNK
 Repeating
Pages
 4. ADVERSE
EVENT 4  Surgical wound sc
alp Oct/27/2020 U
NK:UNK NO
End Date Time:
Jan/21/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133458
Page 33 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[SCALP ABCESS]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/27/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133459
Page 34 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[HISTORY SCALP CYST]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437863]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133460
Page 35 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[SEPSIS]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133461
Page 36 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[SCALP ABCESS ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437863 ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133462
Page 37 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[CELLULITIS UPPER BACK]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133463
Page 38 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[SCALP ABCESS]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437863]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133464
Page 39 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Surgical wound scalp]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133465
Page 40 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Post I&D scalp abcess]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133466
Page 41 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133467
Page 42 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133468
Page 43 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133469
Page 44 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: //
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133470
Page 45 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133471
Page 46 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133472
Page 47 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133473
Page 48 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133474
Page 49 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133475
Page 50 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133476
Page 51 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133477
Page 52 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133478
Page 53 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133479
Page 54 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133480
Page 55 of 173
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133481
Page 56 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133482
Page 57 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133483
Page 58 of 173
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133484
Page 59 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133485
Page 60 of 173
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133486
Page 61 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133487
Page 62 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133488
Page 63 of 173
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133489
Page 64 of 173
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133490
Page 65 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133491
Page 66 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/21/2021
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133492
Page 67 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133493
Page 68 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133494
Page 69 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BRF0PW]
5.bSample ID [BSJSG0]
5.cSample ID [BSJSG1]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133495
Page 70 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BRK9R7]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133496
Page 71 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/21/2021 13:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133497
Page 72 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133498
Page 73 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG1VV]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133499
Page 74 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/11/2021 12:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133500
Page 75 of 173
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133501
Page 76 of 173
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133502
Page 77 of 173
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133503
Page 78 of 173
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133504
Page 79 of 173
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133505
Page 80 of 173
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133506
Page 81 of 173
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133507
Page 82 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/3/2020
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133508
Page 83 of 173
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133509
Page 84 of 173
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133510
Page 85 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-14-2020 13:56:58 (UTC-06:00) Central
Time (US & Canada)Tiffany Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133511
Page 86 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-21-2021 15:12:39 (UTC-06:00) Central
Time (US & Canada)Tiffany Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133512
Page 87 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
Sherri
Pangburn N/A Mar-11-2021 13:41:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Feb-22-2021 11:25:20 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Megan Felty  N/A Feb-11-2021 12:05:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Jan-22-2021 17:53:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133513
Page 88 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, TimothyJennings, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133514
Page 89 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-14-2020 10:52:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020 10:52:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133515
Page 90 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020 10:52:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/14/2020Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133516
Page 91 of 173
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020 10:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10081603Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020 10:52:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020 10:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-14-2020 10:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020 10:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
BLACK OR AFRICAN AMERI
CANInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133517
Page 92 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 10:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133518
Page 93 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-14-2020 10:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 10:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 10:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133519
Page 94 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 08:53:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Sebaceous cys
t of scalp
Start Date: Sep/UNK/202
0
Ongoing: YESunknown
cause,term
updated, on
antibiotic
Oct-14-2020 11:31:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Cyst of scal
p
Start Date: Sep/UNK/2
020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:31:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 06:07:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Oct-16-2020 08:53:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered unknown
cause,term
updated, on
antibiotic
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133520
Page 95 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-16-2020 08:53:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sebaceous cyst of scalpunknown
cause,term
updated, on
antibiotic
Oct-15-2020 15:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Please
further clarify the
medical history
term: type of cyst,
cause, required
treatment.
Oct-14-2020 11:31:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Cyst of scalpInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-14-2020 11:31:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020 11:31:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020 11:31:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Diabetes typ
e II
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133521
Page 96 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:31:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:31:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Diabetes type IIInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020 11:31:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020 11:31:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 11:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Coronary arter
y disease
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133522
Page 97 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:31:52
(UTC-06:00) Central
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-14-2020 11:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Coronary artery diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-14-2020 11:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-14-2020 11:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-14-2020 11:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
1980
Ongoing: YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133523
Page 98 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:32:06
(UTC-06:00) Central
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-14-2020 11:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-14-2020 11:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1980Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-14-2020 11:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-14-2020 11:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:High cholest
erol
Start Date: UNK/UNK/
2014
Ongoing: YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133524
Page 99 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:32:23
(UTC-06:00) Central
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-14-2020 11:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
High cholesterolInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-14-2020 11:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-14-2020 11:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133525
Page 100 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-14-2020 11:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133526
Page 101 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
202.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
68.5Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133527
Page 102 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.4Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 11:30:32
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
FOREHEADInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133528
Page 103 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133529
Page 104 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020 13:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020 13:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
269278Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133530
Page 105 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 11:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 11:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 11:54:39
(UTC-06:00) Central
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-14-2020 11:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 11:54:49
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
Sample ID: BGL5DZInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133531
Page 106 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
BGL5DZInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 11:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID: BPCV02Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 11:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
BPCV02Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020 11:55:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID: BPCV03Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 11:55:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
BPCV03Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133532
Page 107 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 12:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 12:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 12:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 12:49:03
(UTC-06:00) Central
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-14-2020 12:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133533
Page 108 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020 12:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BGL5BHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 12:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGL5BHInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133534
Page 109 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/14/2020 11:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133535
Page 110 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020 13:55:37
(UTC-06:00) Central
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-14-2020 13:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133536
Page 111 of 173
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-14-2020 10:53:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133537
Page 112 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 15:45:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/5/2020Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133538
Page 113 of 173
***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, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/5/2020Initial Entry
2.a
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Record Identifier:
:1
Temperature: 97.6
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) CentralACV0PFEINFP6000  Cheyenne
BrooksData Entry:
FInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133539
Page 114 of 173
***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, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.cbrooks)
2.a Temperature Location:
Date Location User Value Reason
Nov-05-2020 15:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133540
Page 115 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 14:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 14:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 14:39:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 14:39:05
(UTC-06:00) Central
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-05-2020 14:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133541
Page 116 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-05-2020 14:39:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample ID: BRGV1MInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 14:39:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRGV1MInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133542
Page 117 of 173
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/5/2020 15:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133543
Page 118 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-05-2020 15:46:47
(UTC-06:00) Central
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-05-2020 15:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133544
Page 119 of 173
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-03-2020 12:36:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Dec/3/2020Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133545
Page 120 of 173
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 13:10:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 13:10:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 13:10:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 13:10:48
(UTC-06:00) Central
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-03-2020 13:10:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133546
Page 121 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Dec-03-2020 13:10:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample ID: BRD9J6Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 13:10:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRD9J6Initial Entry
5.b
Date Location User Value Reason
Dec-03-2020 13:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample ID: BRT3NSInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-03-2020 13:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRT3NSInitial Entry
5.c
Date Location User Value Reason
Dec-03-2020 13:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample ID: BRT3NTInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-03-2020 13:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRT3NTInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133547
Page 122 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Form Created
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133548
Page 123 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Dec-28-2020 13:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Form Deleted New
Information
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Form Created
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133549
Page 124 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Form Created
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133550
Page 125 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133551
Page 126 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
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-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
SCALP ABCESSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 16:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Nov-09-2020 15:39:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 2: Answered scalp cyst began
9/2020, treated
with bactrim start
09OCT2020, as
noted, abcess
began 26oct2020
Nov-09-2020 12:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL - SAE
reports that the
subject was
receiving
BACTRIM since
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133552
Page 127 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sept as an outpt,
prior to
hospitalization on
26Oct20, for this
scalp cyst. Please
clarify if cyst
infection had onset
on 26Oct20.
Nov-06-2020 17:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-06-2020 17:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Oct/26/2020 UNK:UNKTranscription Error
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For SCALP
ABCESS Start
Date 26/Nov/2020,
is a future date
relative to when it
was entered on
06/Nov/2020.
Please correct.
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Nov/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-23-2020 14:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NO
End Date Time:
Oct/27/2020 UNK:UNKNew Information
Nov-26-2020 09:14:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen
Gayed
(pfe.gayedj)Query 1: Closed Response satisfies
query
Nov-20-2020 11:20:38
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumQuery 1: Answered yes ongoing
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133553
Page 128 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
Nov-20-2020 11:14:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen
Gayed
(pfe.gayedj)Query 1: Opened Clin: Please
confirm if this AE
is still ongoing
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
3Initial 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
Jan-07-2021 16:46:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Jan-05-2021 21:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Deleted Query can be
addressed internally
Dec-28-2020 13:36:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 3: Answered as reported in
follow up narrative,
no other additional
relevant labs/tests
were
performed/noted,
which would
include covid 19
testing
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133554
Page 129 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Dec-25-2020 10:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical COVID test
status (yes/no)
during Hosp was
not reported in the
SAE. Per the DMC
request please
submit a SAE F/U
[#2020437863] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results
Dec-23-2020 14:21:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE SCALP
ABCESS: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-23-2020 14:21:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant dNew Information
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133555
Page 130 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NO
Nov-10-2020 10:58:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-10-2020 08:26:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Query 1: Answered noted
Nov-09-2020 16:51:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical - Thank
you for your
understanding. It is
a request of the
C4591001
independent Data
Monitoring
Committee to
document the
COVID testing
status (YES/NO) for
all hospitalized
subjects, and
Date/Result if YES.
Nov-09-2020 15:46:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 1: Answered no covid testing was
performed on this
subject while
hospitalized. It is a
lot to ask the site to
send in a FU SAE
report to only report
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Page 131 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
whether a covid test
was done or not,
answering the query
should suffice.
Nov-09-2020 14:19:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened CLINICAL -
C4591001
independent Data
Monitoring
Committee has
requested a report
of all COVID
testing when
hospitalized
(YES/NO), and if
date/results if YES.
Clinical relevance is
their overview; so
occult cases are
detected; etc.
Nov-09-2020 14:05:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 1: Answered per SAE completion
guidelines, site to
report any clinically
relevant lab test on
SAE form, covid
testing was not
performed during
this hospital stay as
noted per discharge
summary, no follow
up SAE report
required
Nov-09-2020 12:48:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical COVID test
status (yes/no)
during
Hospitalization has
not been reported in
the SAE submitted
to safety. Please
submit a follow-up
SAE form
[#2020437863] to
document if COVID
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133557
Page 132 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
testing was
performed
(YES/NO) and if
yes, the date and
results.
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)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-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
HISTORY SCALP CYSTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133558
Page 133 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-23-2020 14:22:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-23-2020 14:22:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-23-2020 14:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE SCALP
ABCESS: Response
to "What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020 17:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133559
Page 134 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-05-2021 22:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020437863Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133560
Page 135 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
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-11-2020 20:48:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Query closed; will
follow for SAE
update with the
requested sepsis
info
Nov-11-2020 08:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 1: Answered per PI no other
available test
results per hospital
records received,
will update report
with available vital
signs
Nov-10-2020 11:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL -
Please submit a
SAE safety update
with clinical
documentation for
sepsis (not only
cellulitis),
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Page 136 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
including cultures,
vital signs, or other
evidence of
systemic sepsis
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
SEPSISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Oct/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NO
End Date Time:
Nov/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
3Initial 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
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133562
Page 137 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-07-2021 16:48:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed closing query on a
deleted AE
Dec-28-2020 13:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 3: Answered per updated
information, sepsis
to be removed
Dec-25-2020 10:46:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical Sepsis
Event serious is
reported as YES;
however, SAE
report has no SAE
of Sepsis and
reports that Sepsis
workup was
negative. Please
review, harmonize
reporting and
update in the
appropriate
location.
Nov-09-2020 03:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Closed event recorded in
SDB
Nov-07-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Opened SAE RECON:
SEPSIS(Onset
date:26Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Nov-07-2020 11:04:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Deleted Query can be
addressed internally
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133563
Page 138 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE SEPSIS:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NOInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133564
Page 139 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
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-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
SCALP ABCESSInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133565
Page 140 of 173
***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, Deleted
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)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-06-2020 17:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-09-2020 03:32:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020437863Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133566
Page 141 of 173
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
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
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
CELLULITIS UPPER BACKInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Oct/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NO
End Date Time:
Nov/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133567
Page 142 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
3Initial 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-09-2020 03:32:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Closed SDB entered in
SDB
Nov-07-2020 11:06:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Opened SAE RECON:
CELLULITIS
UPPER
BACK(Onset
date:26Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Nov-07-2020 11:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Deleted Query can be
addressed internally
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
CELLULITIS
UPPER BACK:
Response to "Is the
adverse event
serious?" is 'Yes' but
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133568
Page 143 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
"Serious Adverse
Event Number" is
blank.
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
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-06-2020 17:59:22
(UTC-06:00) CentralACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133569
Page 144 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020
00:12:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Astrud van der Merwe
(pfe.vandea62)Query 1
: ClosedAE#1
Nov-12-2020
08:02:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Query 1
: Answe
redscalp abcess is
what caused
the
CELLULITIS
UPPER
BACK, so yes
its not related
to study
treatment, and
this is the
condition that
lead to
CELLULITIS
UPPER
BACK
Nov-12-2020
03:39:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field [scalp
abcess]. Any
symptoms,
AEs or other
key data
should be
collected on
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133570
Page 145 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
the
appropriate
page. Please
review and
update as
necessary.
"[suryas18
SDQ=48342]"
Nov-06-2020
17:59:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
S
C
A
L
P
A
B
C
E
S
SInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133571
Page 146 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)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-06-2020 17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-09-2020 03:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020437863Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133572
Page 147 of 173
***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
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Surgical wound scalpInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 14:16:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:UNKNew Information
Mar-11-2021 14:00:47 ACV0PFEINFP6000  Tiffany Data Entry: Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133573
Page 148 of 173
***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
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00) Central
Time (US & Canada)Baum
(pfe.tbaum)YES
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)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
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)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
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133574
Page 149 of 173
***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
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Post I&D scalp abcess
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 14:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-11-2021 14:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERED/RESOLVEDNew Information
Mar-11-2021 14:16:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Surgical
wound scalp:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133575
Page 150 of 173
***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
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
is present.
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133576
Page 151 of 173
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-03-2020 12:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020 12:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020 12:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133577
Page 152 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021 08:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Jan/15/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133578
Page 153 of 173
***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
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021 08:47:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 08:46:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-18-2021 08:46:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received o
nly placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133579
Page 154 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-18-2021 08:47:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-18-2021 08:47:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133580
Page 155 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021 15:12:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/21/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133581
Page 156 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-21-2021 15:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Jan/21/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133582
Page 157 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-21-2021 15:12:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/21/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-21-2021 15:12:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-21-2021 15:12:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133583
Page 158 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 15:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 15:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021 15:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021 15:47:24
(UTC-06:00) Central
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-21-2021 15:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133584
Page 159 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-21-2021 15:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
Sample ID: BRF0PWInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-21-2021 15:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
BRF0PWInitial Entry
5.b
Date Location User Value Reason
Jan-21-2021 15:47:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
Sample ID: BSJSG0Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-21-2021 15:47:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
BSJSG0Initial Entry
5.c
Date Location User Value Reason
Jan-21-2021 15:48:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
Sample ID: BSJSG1Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-21-2021 15:48:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
BSJSG1Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133585
Page 160 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 15:15:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 15:15:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021 15:15:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021 15:15:00
(UTC-06:00) Central
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-21-2021 15:15:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133586
Page 161 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-21-2021 15:15:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
Sample ID: BRK9R7Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-21-2021 15:15:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Kim Ringling
(pfe kringling)Data Entry:
BRK9R7Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133587
Page 162 of 173
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/21/2021 13:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133588
Page 163 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-21-2021 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133589
Page 164 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 13:06:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/11/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133590
Page 165 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021 12:05:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021 12:05:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-11-2021 12:06:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-11-2021 12:05:22
(UTC-06:00) Central
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-11-2021 12:05:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Feb/11/2021Initial Entry
5.a
Date Location User Value Reason
Feb-11-2021 12:06:08
(UTC-06:00) CentralACV0PFEINFP6000  Megan
FeltyData Entry:
Sample ID: BRG1VVInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133591
Page 166 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.mfelty)
5.a Sample ID
Date Location User Value Reason
Feb-11-2021 12:06:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRG1VVInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133592
Page 167 of 173
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/11/2021 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133593
Page 168 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-11-2021 13:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133594
Page 169 of 173
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021 13:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Mar/11/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133595
Page 170 of 173
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-11-2021 13:41:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-11-2021 13:41:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Contact:
Mar/11/2021Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133596
Page 171 of 173
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021 13:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Mar/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-11-2021 13:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021 13:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133597
Page 172 of 173
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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1. Subject Status
Date Location User Value Reason
Dec-03-2020 12:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020 13:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-14-2020 10:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-03-2020 12:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/3/2020Initial Entry
Oct-14-2020 13:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Oct-14-2020 10:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133598
Page 173 of 173
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Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081603 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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1. Casebook Signature
Date Location User Value Reason
Dec-03-2020 12:47:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd1\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133599