Document text
Page 1 of 173
***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: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132802
Page 2 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/18/2020
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132803
Page 3 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081056]
2.Birth Date: /1959
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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132804
Page 4 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/18/2020
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132805
Page 5 of 173
***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: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132806
Page 6 of 173
***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: 10081056 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/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132807
Page 7 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:[Diabetes Type II]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Epilepsy]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132808
Page 8 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:[Vitamin B12 deficiency]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132809
Page 9 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [227.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [34.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132810
Page 10 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [232356]
3.Randomization Group: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132811
Page 11 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP51DM]
5.bSample ID [BP51DN]
5.cSample ID [BP51DP]
5.dSample ID [BPRL3N]
5.eSample ID [BPRL3P]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132812
Page 12 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP51C8]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132813
Page 13 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/18/2020 14:58
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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132814
Page 14 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132815
Page 15 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/8/2020
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132816
Page 16 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132817
Page 17 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/8/2020
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 [BPTPLB]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132818
Page 18 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/8/2020 12:30
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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132819
Page 19 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/6/2020
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132820
Page 20 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/6/2020
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 [BGL55F]
5.bSample ID [BRVB69]
5.cSample ID [BRVB6B]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132821
Page 21 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132822
Page 22 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132823
Page 23 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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 [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132824
Page 24 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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 [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132825
Page 25 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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?
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132826
Page 26 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132827
Page 27 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132828
Page 28 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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 [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132829
Page 29 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132830
Page 30 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132831
Page 31 of 173
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132832
Page 32 of 173
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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: [ ]
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FDA-CBER-2021-5683-0132833
Page 33 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132834
Page 34 of 173
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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 [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132835
Page 35 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Injection si
te pain Jan/20/2021 17:
00 NO
End Date Time:
Jan/24/2021 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Shortness o
f breath Mar/UNK/2021
UNK:UNK NO
End Date Time:
Mar/UNK/2021 U
NK:UNK
Repeating
Pages
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132836
Page 36 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Injection site pain]
4.Start Date Time: Jan/20/2021 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/24/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132837
Page 37 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132838
Page 38 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132839
Page 39 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Shortness of breath]
4.Start Date Time: Mar/UNK/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/UNK/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132840
Page 40 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132841
Page 41 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021264468]
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FDA-CBER-2021-5683-0132842
Page 42 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132843
Page 43 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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[ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132844
Page 44 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132845
Page 45 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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FDA-CBER-2021-5683-0132846
Page 46 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132847
Page 47 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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?
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FDA-CBER-2021-5683-0132848
Page 48 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132849
Page 49 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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?
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132850
Page 50 of 173
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132851
Page 51 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132852
Page 52 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132853
Page 53 of 173
***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: 10081056 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:
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132854
Page 54 of 173
***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: 10081056 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?
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132855
Page 55 of 173
***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: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132856
Page 56 of 173
***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: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132857
Page 57 of 173
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/5/2021
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132858
Page 58 of 173
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132859
Page 59 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/20/2021
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132860
Page 60 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132861
Page 61 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132862
Page 62 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132863
Page 63 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF0GR]
5.bSample ID [BSJSJM]
5.cSample ID [BSJSJN]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132864
Page 64 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF0NM]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132865
Page 65 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 12:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132866
Page 66 of 173
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/5/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132867
Page 67 of 173
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132868
Page 68 of 173
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132869
Page 69 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132870
Page 70 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG1S8]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132871
Page 71 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 10:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132872
Page 72 of 173
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132873
Page 73 of 173
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/10/2021
3.Comments: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132874
Page 74 of 173
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132875
Page 75 of 173
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132876
Page 76 of 173
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132877
Page 77 of 173
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132878
Page 78 of 173
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132879
Page 79 of 173
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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/6/2020
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132880
Page 80 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132881
Page 81 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132882
Page 82 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-18-2020 14:30:54 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132883
Page 83 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-20-2021 13:27:39 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132884
Page 84 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Ricell Ann
Piojo N/A Mar-12-2021 08:09:07 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Mar-10-2021 16:23:06 (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.
Sherri
Pangburn N/A Mar-10-2021 15:40:57 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132885
Page 85 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
N/A
Timothy
Jennings Approved Feb-20-2021 19:57:49 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Megan
Felty N/A Feb-10-2021 10:25:53 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Jan-21-2021 14:42:59 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132886
Page 86 of 173
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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.
Tiffany
Baum N/A Jan-07-2021 13:32:45 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Oct-21-2020 16:17:27 (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.
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132887
Page 87 of 173
***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: 10081056 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-18-2020
14:30:23
(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-18-2020
14:30:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132888
Page 88 of 173
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:30:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/18/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132889
Page 89 of 173
***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: 10081056 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-18-2020
14:30:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10081056Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020
14:30:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020
14:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132890
Page 90 of 173
***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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-18-2020
14:30:41
(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-18-2020
14:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
WHITEInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132891
Page 91 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:30:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132892
Page 92 of 173
***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: 10081056 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-18-2020
14:31:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020
14:31:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020
14:31:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132893
Page 93 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:57:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Diabetes
Type II
Start Date: UNK/U
NK/201
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020
14:57:03
(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-18-2020
14:57:03
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Diabetes Type IIInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132894
Page 94 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-18-2020
14:57:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020
14:57:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-18-2020
14:57:17
(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
3
Ongoing: YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132895
Page 95 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:57:17
(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-18-2020
14:57:17
(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-18-2020
14:57:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2013Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020
14:57:17ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132896
Page 96 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:57:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Epilepsy
Start Date: UNK/U
NK/200
7
Ongoing: YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132897
Page 97 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:57:56
(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-18-2020
14:57:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
EpilepsyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020
14:57:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2007Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020
14:57:56ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132898
Page 98 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:01:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:Vitamin B
12 deficie
ncy
Start Date
:UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132899
Page 99 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:01:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020
15:01:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Vitamin B12 deficienc
yInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020
15:01:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020
15:01:06ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132900
Page 100 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132901
Page 101 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
227.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132902
Page 102 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020
15:01:43
(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-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.5Initial Entry
7.a
Date Location User Value Reason
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:97.4Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132903
Page 103 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:01:43
(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-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132904
Page 104 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020
15:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132905
Page 105 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
232356Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132906
Page 106 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:31:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
14:31:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020
15:42:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
14:31:16
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132907
Page 107 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:31:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
15:42:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID
:BP51D
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
15:42:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BP51DMInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132908
Page 108 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-18-2020
15:42:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID
:BP51D
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020
15:42:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BP51DNInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020
15:42:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID: BP51DPInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020
15:42:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BP51DPInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132909
Page 109 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d
Date Location User Value Reason
Aug-18-2020
15:44:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID
:BPRL3
NInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
15:44:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BPRL3NInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020
15:44:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID: BPRL3PInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132910
Page 110 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
15:44:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BPRL3PInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132911
Page 111 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:31:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020
14:31:23
(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-18-2020
15:39:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
14:31:23
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132912
Page 112 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
14:31:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
15:39:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sample ID: BP51C8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
15:39:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
BP51C8Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132913
Page 113 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:46:18
(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-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132914
Page 114 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Aug/18/2020 14:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020
15:46:18
(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-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132915
Page 115 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-18-2020
15:46:18
(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-18-2020
15:46:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132916
Page 116 of 173
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-19-2020
09:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTTranscription
Error
Aug-18-2020
14:31:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132917
Page 117 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-08-2020
13:13:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/8/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132918
Page 118 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10081056 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-08-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:97.5
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132919
Page 119 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020
13:13:42
(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-08-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132920
Page 120 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-08-2020
13:05:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020
13:05:36
(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-08-2020
13:05:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
13:05:36
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132921
Page 121 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-08-2020
13:05:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
13:05:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTPL
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
13:05:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTPLBInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132922
Page 122 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-08-2020
13:14:17
(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-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132923
Page 123 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/8/2020 12:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020
13:14:17
(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-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132924
Page 124 of 173
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-08-2020
13:14:17
(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-08-2020
13:14:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132925
Page 125 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-06-2020
10:48:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132926
Page 126 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-06-2020
13:16:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
13:16:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
13:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
13:16:15
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132927
Page 127 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-06-2020
13:16:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
13:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BGL55
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
13:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGL55FInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132928
Page 128 of 173
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-06-2020
13:16:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BRVB6
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020
13:16:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRVB69Initial Entry
5.c
Date Location User Value Reason
Oct-06-2020
13:16:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BRVB6
BInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020
13:16:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRVB6BInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132929
Page 129 of 173
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-06-2020
10:49:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020
10:49:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020
10:49:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132930
Page 130 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132931
Page 131 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Form Created
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132932
Page 132 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132933
Page 133 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/20/2021 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Jan/24/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132934
Page 134 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132935
Page 135 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132936
Page 136 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-10-2021
11:15:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132937
Page 137 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021
07:55:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Query 1: Answere
dsubject did not
report
anything to
site, its well
past the time
for subject to
swab per
protocol now.
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132938
Page 138 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021
07:43:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened PDCLIN: Per
protocol
section 8.1,
COVID-19
listed
symptom
Shortness of
breath should
have please
triggered a
potential
COVID
Illness Visit
irrespective of
perceived
etiology or
clinical
significance .
Please
complete the
potential
COVID
Illness CRF
forms
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Shortness of breat
hInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132939
Page 139 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Mar/UNK/2021 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NO
End Date Time:
Mar/UNK/2021
UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132940
Page 140 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-12-2021
14:18:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Mar-12-2021
08:09:07
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
08:05:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Query 2: Answer
edany SAE we
request medical
records,medical
records have
been request,
they have 90
days to give site
records
Mar-11-2021
20:15:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical - please
request medical
records for the
admission,
including any
COVID test
performed in
hospital
Mar-10-2021
15:46:03
(UTC-06:00)
Central TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE
Shortness of
breath:
Response to "Is
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132941
Page 141 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospita
lization?
YES
Did this serious
event result in p
ersistent or sign
ificant disabilitInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132942
Page 142 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
y/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-10-2021
15:46:41
(UTC-06:00)
Central TimeACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOT RELATED
If Not Related to
study treatment(sTranscription
Error
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132943
Page 143 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) ), this event is du
e to:
OTHER
If Other, speci
fy:
unknown
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132944
Page 144 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-10-2021
15:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-12-2021
08:09:07ACV0PFEINFP6000 Ricell Ann
PiojoData Entry:
2021264468Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132945
Page 145 of 173
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.quitor)
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132946
Page 146 of 173
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-07-2021
13:33:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/5/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132947
Page 147 of 173
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-07-2021
13:34:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per local/n
ational recommend
ations and confirm
ed to have received
only placebo at Vac
cination 1/2Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132948
Page 148 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-20-2021
13:27:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/20/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132949
Page 149 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-20-2021
13:27:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Jan/20/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132950
Page 150 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-20-2021
13:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/20/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-20-2021
13:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-20-2021
13:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132951
Page 151 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021
14:59:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021
14:59:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021
14:59:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-20-2021
14:59:01
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132952
Page 152 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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.
Jan-20-2021
14:59:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/20/2021Initial Entry
5.a
Date Location User Value Reason
Jan-20-2021
14:59:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRF0G
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021
14:59:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
BRF0GRInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132953
Page 153 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-20-2021
14:59:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BSJSJMInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-20-2021
14:59:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
BSJSJMInitial Entry
5.c
Date Location User Value Reason
Jan-20-2021
14:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BSJSJNInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-20-2021
14:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
BSJSJNInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132954
Page 154 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021
15:37:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021
15:37:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021
15:37:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-20-2021
15:37:39
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132955
Page 155 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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.
Jan-20-2021
15:37:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/20/2021Initial Entry
5.a
Date Location User Value Reason
Jan-20-2021
15:37:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRF0N
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021
15:37:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
BRF0NMInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132956
Page 156 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132957
Page 157 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/20/2021 12:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132958
Page 158 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-20-2021
13:27:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-20-2021
13:27:01ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132959
Page 159 of 173
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132960
Page 160 of 173
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-07-2021
13:32:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-07-2021
13:32:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132961
Page 161 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
11:15:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/10/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132962
Page 162 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
10:25:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
10:25:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
10:26:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
10:25:53
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132963
Page 163 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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.
Feb-10-2021
10:25:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
10:26:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRG1S
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
10:26:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Megan
Felty
(pfe.mfelty)Data Entry:
BRG1S8Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132964
Page 164 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132965
Page 165 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/10/2021 10:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132966
Page 166 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-10-2021
11:16:10ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132967
Page 167 of 173
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132968
Page 168 of 173
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
15:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Mar/10/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132969
Page 169 of 173
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-10-2021
15:41:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-10-2021
15:41:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Contact:
Mar/10/2021Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132970
Page 170 of 173
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-10-2021
15:41:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021
15:41:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021
15:41:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132971
Page 171 of 173
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-06-2020
10:49:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-18-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-18-2020
14:31:05
(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-06-2020
10:49:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Aug-18-2020
15:45:54ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132972
Page 172 of 173
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)
Aug-18-2020
14:31:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132973
Page 173 of 173
***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, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081056 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-17-2020
12:23:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd2\Final\Final On: 01-Apr-2021 05:23 (GMT)
FDA-CBER-2021-5683-0132974