125742 S1 M5 CRF c4591001 1008 10081667

Document text

Page 1 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133767
Page 2 of 186
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/22/2020
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133768
Page 3 of 186
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081667]
2.Birth Date: 1941
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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133769
Page 4 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/22/2020
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133770
Page 5 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133771
Page 6 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133772
Page 7 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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:[Asthma]
Start Date: UNK/UNK/1976
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Non allergic rhinitis]
Start Date: UNK/UNK/1945
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133773
Page 8 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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:[Diabetes type II]
Start Date: UNK/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Penicillin allergy]
Start Date: UNK/UNK/1957
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Levaquin allergy]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133774
Page 9 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133775
Page 10 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
2.Weight: [177.6]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [26.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133776
Page 11 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/22/2020
2.Randomization Number: [272026]
3.Randomization Group: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133777
Page 12 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBH6]
5.bSample ID [BRZDBC]
5.cSample ID [BRZDBD]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133778
Page 13 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZBG6]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133779
Page 14 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/22/2020 11:33
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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133780
Page 15 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133781
Page 16 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133782
Page 17 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133783
Page 18 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGV3S]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133784
Page 19 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/12/2020 09:29
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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133785
Page 20 of 186
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133786
Page 21 of 186
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRL1RY]
5.bSample ID [BS96NF]
5.cSample ID [BS96NG]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133787
Page 22 of 186
***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: 10081667 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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133788
Page 23 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133789
Page 24 of 186
***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: 10081667 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 [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133790
Page 25 of 186
***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: 10081667 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 [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133791
Page 26 of 186
***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: 10081667 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?
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133792
Page 27 of 186
***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: 10081667 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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133793
Page 28 of 186
***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: 10081667 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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133794
Page 29 of 186
***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: 10081667 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 [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133795
Page 30 of 186
***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: 10081667 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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133796
Page 31 of 186
***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: 10081667 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 [ ]
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FDA-CBER-2021-5683-0133797
Page 32 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  injection site a
re soreness Nov/12/2020
19:30 NO
End Date Time:
Nov/13/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  liver cancer  Feb/25/2021
UNK:UNK YES  Repeating
Pages
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133798
Page 33 of 186
***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: 10081667 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 are soreness]
4.Start Date Time: Nov/12/2020 19:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/13/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133799
Page 34 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133800
Page 35 of 186
***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: 10081667 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[ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133801
Page 36 of 186
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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)[liver cancer]
4.Start Date Time: Feb/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133802
Page 37 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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?
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133803
Page 38 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?YES
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021240864]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133804
Page 39 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133805
Page 40 of 186
***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: 10081667 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[ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133806
Page 41 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133807
Page 42 of 186
***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: 10081667 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: //
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133808
Page 43 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133809
Page 44 of 186
***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: 10081667 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?
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133810
Page 45 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133811
Page 46 of 186
***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: 10081667 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?
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133812
Page 47 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133813
Page 48 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133814
Page 49 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133815
Page 50 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133816
Page 51 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133817
Page 52 of 186
***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: 10081667 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:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133818
Page 53 of 186
***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: 10081667 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?
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133819
Page 54 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133820
Page 55 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133821
Page 56 of 186
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133822
Page 57 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133823
Page 58 of 186
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133824
Page 59 of 186
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [3/10/21 withdrew consent, refuses study FU/further
contact/medical records request]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133825
Page 60 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133826
Page 61 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133827
Page 62 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133828
Page 63 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133829
Page 64 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021
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 [BRF55N]
5.bSample ID [BSCBDB]
5.cSample ID [BSCBDC]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133830
Page 65 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021
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 [BRF5DY]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133831
Page 66 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/13/2021 10:46
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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133832
Page 67 of 186
***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: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133833
Page 68 of 186
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Mar/10/2021
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133834
Page 69 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133835
Page 70 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/3/2021
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133836
Page 71 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/3/2021
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 [BRKB0P]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133837
Page 72 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/3/2021 10:32
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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133838
Page 73 of 186
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/4/2021
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133839
Page 74 of 186
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/4/2021
3.Comments: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133840
Page 75 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133841
Page 76 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133842
Page 77 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133843
Page 78 of 186
***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: 10081667 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: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133844
Page 79 of 186
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133845
Page 80 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Mar/10/2021
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133846
Page 81 of 186
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133847
Page 82 of 186
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Mar-11-2021 11:18:35 (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.
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133848
Page 83 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-22-2020 11:01:10 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133849
Page 84 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-13-2021 10:38:44 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133850
Page 85 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Mar-11-2021 11:18:35 (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.
Ann Patek  N/A Mar-11-2021 10:16:27 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Mar-10-2021 21:52:08 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133851
Page 86 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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 Mar-05-2021 08:10:26 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Feb-22-2021 18:09:47 (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.
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133852
Page 87 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Tiffany
Baum N/A Feb-03-2021 11:32:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Jan-22-2021 18:33:34 (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.
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133853
Page 88 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-22-2020
10:59:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-22-2020
10:59:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133854
Page 89 of 186
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-22-2020
10:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Oct/22/2020Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133855
Page 90 of 186
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-22-2020
10:59:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10081667Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-22-2020
10:59:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1941Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-22-2020
10:59:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133856
Page 91 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-22-2020
10:59:58
(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
Oct-22-2020
10:59:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
WHITEInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133857
Page 92 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:00:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133858
Page 93 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:00:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
11:00:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
11:00:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133859
Page 94 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-22-2020
11:14:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Asthma
Start Date: UNK/U
NK/197
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:14:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:14:54
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
AsthmaInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133860
Page 95 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-22-2020
11:14:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1976Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-22-2020
11:14:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-13-2021
15:20:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Non alle
rgic rhin
itis
Start Date
:UNK/U
NK/194
5New
Information
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133861
Page 96 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: YES
Oct-22-2020
11:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Seasona
l allergi
es
Start Date
:UNK/U
NK/194
5
Ongoing: YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133862
Page 97 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:15:19
(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
Jan-13-2021
15:20:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Non allergic rhinitisNew
Information
Oct-22-2020
11:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Seasonal allergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-22-2020
11:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1945Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133863
Page 98 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Ongoing:
Date Location User Value Reason
Oct-22-2020
11:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-22-2020
11:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History
Term:Gastroesop
hageal reflu
x disease
Start Dat
e:UNK/UNK/
2005
Ongoing
:YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133864
Page 99 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Gastroesophageal refl
ux diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-22-2020
11:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-22-2020
11:15:38ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133865
Page 100 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
Oct-22-2020
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Diabetes
type II
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133866
Page 101 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Diabetes type IIInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-22-2020
11:16:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-22-2020
11:16:10ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133867
Page 102 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.e
Date Location User Value Reason
Oct-22-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133868
Page 103 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-22-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-22-2020
11:16:24ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133869
Page 104 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.f
Date Location User Value Reason
Oct-22-2020
11:16:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Penicilli
n allergy
Start Date: UNK/U
NK/195
7
Ongoing: YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133870
Page 105 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:16:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:16:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Penicillin allergyInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-22-2020
11:16:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1957Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-22-2020
11:16:51ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133871
Page 106 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.g
Date Location User Value Reason
Oct-22-2020
11:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Levaqui
n allergy
Start Date: UNK/U
NK/201
4
Ongoing: YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133872
Page 107 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Oct-22-2020
11:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
11:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Levaquin allergyInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-22-2020
11:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-22-2020
11:17:05ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133873
Page 108 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133874
Page 109 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-22-2020
11:01:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133875
Page 110 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
177.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133876
Page 111 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-22-2020
11:14:35
(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
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.2Initial Entry
7.a
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:97.3Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133877
Page 112 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133878
Page 113 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a Temperature Location:
Date Location User Value Reason
Oct-22-2020
11:14:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133879
Page 114 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-22-2020
12:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-22-2020
12:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
272026Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133880
Page 115 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:16:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
11:16:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
11:16:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
11:16:17
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133881
Page 116 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:16:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
11:16:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPZBH
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
11:16:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPZBH6Initial Entry
5.b
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133882
Page 117 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-22-2020
11:16:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BRZDB
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
11:16:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDBCInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
11:16:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample I
D:BRZDB
DInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
11:16:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDBDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133883
Page 118 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:16:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
11:16:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
11:16:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
11:16:47
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133884
Page 119 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-22-2020
11:16:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
11:16:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPZBG
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
11:16:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPZBG6Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133885
Page 120 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133886
Page 121 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020 11:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133887
Page 122 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-22-2020
12:16:07
(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
Oct-22-2020
12:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133888
Page 123 of 186
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-22-2020
11:00:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133889
Page 124 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020
10:09:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/12/2020Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133890
Page 125 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/12/2020Initial Entry
2.a
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.0
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
1Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133891
Page 126 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Temperature:
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-12-2020
10:09:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133892
Page 127 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020
10:37:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020
10:37:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020
10:37:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-12-2020
10:37:38
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133893
Page 128 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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.
Nov-12-2020
10:37:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Collectio
n:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020
10:37:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BRGV3
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020
10:37:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRGV3SInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133894
Page 129 of 186
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133895
Page 130 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Nov/12/2020 09:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133896
Page 131 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-12-2020
10:10:20
(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
Nov-12-2020
10:10:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133897
Page 132 of 186
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-10-2020
10:27:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Dec/10/2020Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133898
Page 133 of 186
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020
11:40:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020
11:40:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020
11:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-10-2020
11:40:01
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133899
Page 134 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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.
Dec-10-2020
11:40:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Collectio
n:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-10-2020
11:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BRL1R
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-10-2020
11:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRL1RYInitial Entry
5.b
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133900
Page 135 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Dec-10-2020
11:40:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BS96N
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-10-2020
11:40:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BS96NFInitial Entry
5.c
Date Location User Value Reason
Dec-10-2020
11:40:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BS96N
GInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133901
Page 136 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Dec-10-2020
11:40:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Sherri
Pangburn
(pfe.spangburn)Data Entry:
BS96NGInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133902
Page 137 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133903
Page 138 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133904
Page 139 of 186
***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: 10081667 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-05-2021
08:12:14
(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-05-2021
08:12:14
(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
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
injection site are soren
essInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133905
Page 140 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Nov/12/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Nov/13/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
08:12:14
(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).
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133906
Page 141 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021
08:12:14
(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
Mar-05-2021
08:12:14
(UTC-06:00)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133907
Page 142 of 186
***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: 10081667 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
Mar-05-2021
08:12:14
(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
Mar-05-2021
08:12:14
(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
Mar-05-2021
08:12:14
(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?
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133908
Page 143 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-05-2021
08:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133909
Page 144 of 186
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-05-2021
08:18:03
(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-05-2021
08:18:03
(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-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
liver cancerInitial Entry
4. Start Date Time:
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133910
Page 145 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-11-2021
10:22:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Feb/25/2021 UNK:U
NKNew
Information
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/UNK/2021 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021
12:04:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Elizabeth
Chatburn
(pfe.chatbe)Query 1: Closed subject refuses
to allow any
further follow
up
Mar-11-2021
10:22:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 1: Answered 3/10/21 subject
withdrew
consent,
refuses any
further FU in
study, refuses
any further
contact, refuses
to allow for
medical
records request
by site/sponsor,
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133911
Page 146 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
event is
ongoing
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up
form is
completed and
this Adverse
Event is still
ongoing.
Please review
and update as
appropriate.
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)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;
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133912
Page 147 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-07-2021
23:35:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-05-2021
14:57:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 2: Closed Response
satisfies query
Mar-05-2021
09:07:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Query 2: Answer
edOther
medically
important
serious event
YES
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse
event
serious?' is
reported 'Yes',
but at least
one
seriousness
criteria is
missing.
Please review
and update as
appropriate.
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133913
Page 148 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teFor AE liver
cancer:
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)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 result in p
ersistent or sign
ificant disabilit
y/incapacity?Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133914
Page 149 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important serio
us event
YES
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-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133915
Page 150 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021
04:09:41
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Mar-08-2021
14:29:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Query 1: Answer
edinitial SAE report
narrative states site
will update once
records/additional
info available, not
best practice to
leave queries open,
medical records
requests/processing
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133916
Page 151 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
can take up to 90
days, no expected
delays, site will
update when able
Mar-08-2021
13:40:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Reissue
d:OpenedGPDCLIN: Per
response to query-
waiting on records
to update therapy.
Please clarify when
do you expect to
have the data
available. Please
consider keeping
the query open and
respond only once
updates can be
made. if a delay is
expected, please
clarify.
Mar-08-2021
07:54:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 1: Answer
edwaiting on records
to update
Mar-07-2021
15:22:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Liver
Cancer- please
clarify if subject
was treated
(surgery,
chemotherapy etc.)
and if yes, please
update this page
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133917
Page 152 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
accordingly. If a
per protocol
prohibited
systemic therapy
was given, please
also update
PROHIB CM
page. Else, please
clarify.
Mar-05-2021
08:18:03
(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
Mar-05-2021
08:18:03
(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
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133918
Page 153 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
15:07:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ute Frantz
(pfe.frantu)Query 1: Closed Response
satisfies query
Mar-12-2021
10:49:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 1: Answered subject chose
to withdrawl
due to dx,
status is not
fatal so that is
why FUP status
is not AE
Mar-12-2021
10:20:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened DM: "Did the
event cause the
Subject to be
Discontinued
from the
Study" on AE
form is YES
and AE
outcome is not
FATAL and
FUP status is
not ADVERSE
EVENT. Please
verify and
confirm. Thank
you.
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133919
Page 154 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021
10:16:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YES3/10/21 subject
withdrew
consent,
refuses any
further FU in
study, refuses
any further
contact, refuses
to allow for
medical
records request
by site/sponsor.
Mar-05-2021
08:18:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-07-2021
23:35:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021240864Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133920
Page 155 of 186
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-10-2020
10:29:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-10-2020
10:29:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-10-2020
10:29:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133921
Page 156 of 186
***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: 10081667 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
13:31:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/5/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133922
Page 157 of 186
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
13:32:02
(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
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133923
Page 158 of 186
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
WITHDRAWAL BY
SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133924
Page 159 of 186
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
3/10/21 withdrew con
sent, refuses study FU
/further contact/medic
al records requestInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133925
Page 160 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
10:38:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133926
Page 161 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
10:38:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Jan/13/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133927
Page 162 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
10:38:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-13-2021
10:38:56
(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-13-2021
10:38:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133928
Page 163 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
14:45:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021
14:45:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021
14:45:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-13-2021
14:45:13
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133929
Page 164 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
14:45:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021
14:45:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRF55
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021
14:45:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRF55NInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133930
Page 165 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-13-2021
14:45:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BSCBD
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021
14:45:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BSCBDBInitial Entry
5.c
Date Location User Value Reason
Jan-13-2021
14:46:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BSCBD
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-13-2021
14:46:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BSCBDCInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133931
Page 166 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
14:11:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021
14:11:32
(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-13-2021
14:11:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-13-2021
14:11:32
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133932
Page 167 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
14:11:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021
14:11:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRF5D
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021
14:11:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRF5DYInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133933
Page 168 of 186
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-13-2021
11:30:41
(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-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133934
Page 169 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021 10:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-13-2021
11:30:41
(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-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133935
Page 170 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Jan-13-2021
11:30:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-13-2021
11:30:41
(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-13-2021
11:30:41
(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-13-2021
11:30:41ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133936
Page 171 of 186
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133937
Page 172 of 186
***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: 10081667 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
13:31:38
(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
13:31:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133938
Page 173 of 186
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Mar-11-2021
10:16:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Mar/10/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133939
Page 174 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-03-2021
11:32:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/3/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133940
Page 175 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-03-2021
12:25:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
12:25:10
(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-03-2021
12:25:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
12:25:10
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133941
Page 176 of 186
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-03-2021
12:25:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
12:25:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID
:BRKB0
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
12:25:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRKB0PInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133942
Page 177 of 186
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-03-2021
11:32:53
(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-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133943
Page 178 of 186
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/3/2021 10:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021
11:32:53
(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-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133944
Page 179 of 186
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021
11:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021
11:32:53
(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-03-2021
11:32:53
(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-03-2021
11:32:53ACV0PFEINFP6000  Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133945
Page 180 of 186
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133946
Page 181 of 186
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-05-2021
08:10:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Mar/4/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133947
Page 182 of 186
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-05-2021
08:10:38
(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-05-2021
08:10:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Contact:
Mar/4/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133948
Page 183 of 186
***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, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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-05-2021
09:06:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Mar/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-05-2021
09:06:29
(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-05-2021
09:06:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133949
Page 184 of 186
***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: 10081667 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
Mar-11-2021
10:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Dec-10-2020
10:29:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-22-2020
12:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-22-2020
11:00:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-11-2021
10:19:46ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Mar/10/2021Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133950
Page 185 of 186
***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: 10081667 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)
Dec-10-2020
10:29:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-22-2020
12:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-22-2020
11:00:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133951
Page 186 of 186
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081667 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
Dec-10-2020
10:29:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd6\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133952