125742 S1 M5 CRF c4591001 1008 10081152

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
124
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 124
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132975
Page 2 of 124
***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: 10081152 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
Aug/31/2020
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132976
Page 3 of 124
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081152]
2.Birth Date: 1979
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132977
Page 4 of 124
***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: 10081152 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 Aug/31/2020
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132978
Page 5 of 124
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132979
Page 6 of 124
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132980
Page 7 of 124
***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: 10081152 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:[Seasonal allergies]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Percocet allergy]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132981
Page 8 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tinea Versicolor]
Start Date: May/UNK/2020
Ongoing: YES
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132982
Page 9 of 124
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [228.2]
3.Unit: LB
4.Height: [74.5]
5.Unit: in
6.Body Mass Index: [28.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132983
Page 10 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [75850]
3.Randomization Group: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132984
Page 11 of 124
***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: 10081152 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:
Aug/31/2020
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 [BPTPN0]
5.bSample ID [BPTPN1]
5.cSample ID [BPTPN2]
5.dSample ID [BPRL7M]
5.eSample ID [BPRL7N]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132985
Page 12 of 124
***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: 10081152 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:
Aug/31/2020
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 [BP51LF]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132986
Page 13 of 124
***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: 10081152 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: Aug/31/2020 15:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132987
Page 14 of 124
***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: 10081152 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
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132988
Page 15 of 124
***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: 10081152 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 Sep/21/2020
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132989
Page 16 of 124
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132990
Page 17 of 124
***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: 10081152 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:
Sep/21/2020
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 [BGK0Y3]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132991
Page 18 of 124
***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: 10081152 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: Sep/21/2020 14:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132992
Page 19 of 124
***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: 10081152 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/19/2020
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132993
Page 20 of 124
***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: 10081152 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/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGL5BM]
5.bSample ID [BRZDBV]
5.cSample ID [BRZDBW]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132994
Page 21 of 124
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132995
Page 22 of 124
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132996
Page 23 of 124
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132997
Page 24 of 124
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132998
Page 25 of 124
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132999
Page 26 of 124
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133000
Page 27 of 124
***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: 10081152 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:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133001
Page 28 of 124
***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: 10081152 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: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133002
Page 29 of 124
***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: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133003
Page 30 of 124
***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: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133004
Page 31 of 124
***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: 10081152 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?
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133005
Page 32 of 124
***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: 10081152 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:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133006
Page 33 of 124
***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: 10081152 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:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133007
Page 34 of 124
***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: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133008
Page 35 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133009
Page 36 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133010
Page 37 of 124
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133011
Page 38 of 124
***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: 10081152 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: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133012
Page 39 of 124
***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: 10081152 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:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133013
Page 40 of 124
***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: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133014
Page 41 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133015
Page 42 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133016
Page 43 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133017
Page 44 of 124
***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: 10081152 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[ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133018
Page 45 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-D
efined Ide
ntifierCategory f
or Medica
tionConcomitant M
edications Pre-s
pecifiedName of MedicationStart
DateForm Insta
nce
 1.1  VACCINA
TIONS NO  Quadrivalent flu prophyl
axis intramuscular vaccin
e 0.5 ml once Oct/8
/202
0 Repeating
Pages
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133019
Page 46 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Quadrivalent flu prophylaxis intramuscular vaccine 0.5 ml
once]
5.Date: Oct/8/2020
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133020
Page 47 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133021
Page 48 of 124
***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: 10081152 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?
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133022
Page 49 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133023
Page 50 of 124
***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: 10081152 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?
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133024
Page 51 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133025
Page 52 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133026
Page 53 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133027
Page 54 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10081152 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:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133028
Page 55 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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?
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133029
Page 56 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10081152 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: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133030
Page 57 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10081152 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: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133031
Page 58 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133032
Page 59 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133033
Page 60 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133034
Page 61 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133035
Page 62 of 124
***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: 10081152 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/7/2021
2.Erroneous Visit
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133036
Page 63 of 124
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133037
Page 64 of 124
***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: 10081152 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/7/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133038
Page 65 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133039
Page 66 of 124
***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: 10081152 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: [ ]
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133040
Page 67 of 124
***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: 10081152 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 Oct/19/2020
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133041
Page 68 of 124
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133042
Page 69 of 124
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Jan-21-2021 16:49:56 (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.
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133043
Page 70 of 124
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-31-2020 15:01:26 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133044
Page 71 of 124
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Jan-21-2021 16:49:56 (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.
Tonya
Clausen N/A Jan-08-2021 15:49:40 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Oct-29-2020 15:53:47 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133045
Page 72 of 124
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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.
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133046
Page 73 of 124
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
Aug-31-2020
15:00:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020
15:00:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133047
Page 74 of 124
***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: 10081152 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
Aug-31-2020
15:01:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/31/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133048
Page 75 of 124
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
Aug-31-2020
15:00:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10081152Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020
15:00:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1979Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020
15:01:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133049
Page 76 of 124
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
15:01:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020
15:01:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
WHITEInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133050
Page 77 of 124
***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: 10081152 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
Aug-31-2020
15:01:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133051
Page 78 of 124
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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
Aug-31-2020
15:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020
15:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020
15:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133052
Page 79 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020
15:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:Seasonal
allergies
Start Date: UNK/U
NK/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020
15:01:53
(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
Aug-31-2020
15:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Seasonal allergiesInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133053
Page 80 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Start Date:
Date Location User Value Reason
Aug-31-2020
15:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020
15:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-31-2020
15:02:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/201
8
Ongoing: YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133054
Page 81 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020
15:02:26
(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
Aug-31-2020
15:02:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020
15:02:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020
15:02:26ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133055
Page 82 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.c
Date Location User Value Reason
Aug-31-2020
15:03:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Percocet
allergy
Start Date: UNK/U
NK/199
8
Ongoing: YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133056
Page 83 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020
15:03:15
(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
Aug-31-2020
15:03:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Percocet allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020
15:03:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1998Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020
15:03:15ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133057
Page 84 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.d
Date Location User Value Reason
Aug-31-2020
16:10:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Tinea Ve
rsicolor
Start Date: May/UN
K/2020
Ongoing: YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133058
Page 85 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020
16:10:22
(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
Aug-31-2020
16:10:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Tinea VersicolorInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020
16:10:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
May/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020
16:10:22ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133059
Page 86 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133060
Page 87 of 124
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
228.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133061
Page 88 of 124
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
74.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020
15:04:24
(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
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.9Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:98.0Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133062
Page 89 of 124
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133063
Page 90 of 124
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
15:04:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133064
Page 91 of 124
***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: 10081152 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
Aug-31-2020
16:08:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020
16:08:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
75850Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133065
Page 92 of 124
***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: 10081152 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
Aug-31-2020
15:04:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
15:04:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
15:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
15:04:32
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133066
Page 93 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
15:04:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
15:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTPN
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
15:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTPN0Initial Entry
5.b
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133067
Page 94 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
15:22:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTPN
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020
15:22:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTPN1Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020
15:22:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTPN
2Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020
15:22:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTPN2Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133068
Page 95 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d
Date Location User Value Reason
Aug-31-2020
15:22:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BPRL7
MInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020
15:22:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPRL7MInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020
15:22:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPRL7
NInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133069
Page 96 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.e Sample ID
Date Location User Value Reason
Aug-31-2020
15:22:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPRL7NInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133070
Page 97 of 124
***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: 10081152 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
Aug-31-2020
15:04:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
15:04:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
15:23:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
15:04:39
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133071
Page 98 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
15:04:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
15:23:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BP51L
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
15:23:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BP51LFInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133072
Page 99 of 124
***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: 10081152 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
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133073
Page 100 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/31/2020 15:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133074
Page 101 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-31-2020
16:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133075
Page 102 of 124
***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: 10081152 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
Aug-31-2020
15:04:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133076
Page 103 of 124
***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: 10081152 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
Sep-21-2020
15:05:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/21/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133077
Page 104 of 124
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:98.2
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133078
Page 105 of 124
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Temperature:
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020
15:05:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133079
Page 106 of 124
***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: 10081152 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
Sep-21-2020
14:38:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020
14:38:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020
14:38:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020
14:38:35
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133080
Page 107 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-21-2020
14:38:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020
14:38:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BGK0Y
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
14:38:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGK0Y3Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133081
Page 108 of 124
***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: 10081152 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
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133082
Page 109 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/21/2020 14:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133083
Page 110 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-21-2020
15:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133084
Page 111 of 124
***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: 10081152 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-19-2020
15:02:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/19/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133085
Page 112 of 124
***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: 10081152 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-19-2020
15:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
15:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
15:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
15:36:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133086
Page 113 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-19-2020
15:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
15:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BGL5B
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
15:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGL5BMInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133087
Page 114 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-19-2020
15:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BRZDB
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
15:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDBVInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
15:37:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BRZDB
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
15:37:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDBWInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133088
Page 115 of 124
***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, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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-19-2020
15:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
15:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
15:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133089
Page 116 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133090
Page 117 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133091
Page 118 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Quadrivalent flu prop
hylaxis intramuscular
vaccine 0.5 ml onceInitial Entry
5. Date:
Date Location User Value Reason
Oct-19-2020
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/8/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133092
Page 119 of 124
***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: 10081152 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-08-2021
15:49:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tonya
Clausen
(pfe.tclausen)Data Entry:
Jan/7/2021Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133093
Page 120 of 124
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 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-08-2021
15:50:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tonya
Clausen
(pfe.tclausen)Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible and NOT
confirmed to have
received only plac
ebo at Vaccination
1/2Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133094
Page 121 of 124
***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: 10081152 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-08-2021
15:49:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tonya
Clausen
(pfe.tclausen)Data Entry:
Jan/7/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-08-2021
15:49:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tonya
Clausen
(pfe.tclausen)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133095
Page 122 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020
15:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020
16:08:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-31-2020
15:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020
15:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-31-2020
16:08:51ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133096
Page 123 of 124
***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: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)
Aug-31-2020
15:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133097
Page 124 of 124
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081152 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-19-2020
15:02:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd3\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0133098
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