125742 S1 M5 CRF c4591001 1085 10851246

Document text

Page 1 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021730
Page 2 of 158
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021731
Page 3 of 158
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10851246]
2.Birth Date: /1987
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021732
Page 4 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021733
Page 5 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021734
Page 6 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021735
Page 7 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021736
Page 8 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [247.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [38.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021737
Page 9 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021738
Page 10 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [78304]
3.Randomization Group: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021739
Page 11 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP5BLN]
5.bSample ID [BNVT60]
5.cSample ID [BNVT61]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021740
Page 12 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP5BJ6]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021741
Page 13 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 14:00
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
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021742
Page 14 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021743
Page 15 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021744
Page 16 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021745
Page 17 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021746
Page 18 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP9N88]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021747
Page 19 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 12:04
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
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021748
Page 20 of 158
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021749
Page 21 of 158
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BNZKP3]
5.bSample ID [BS7W2P]
5.cSample ID [BS7W2R]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021750
Page 22 of 158
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021751
Page 23 of 158
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021752
Page 24 of 158
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021753
Page 25 of 158
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021754
Page 26 of 158
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021755
Page 27 of 158
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021756
Page 28 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021757
Page 29 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021758
Page 30 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021759
Page 31 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021760
Page 32 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021761
Page 33 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021762
Page 34 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021763
Page 35 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021764
Page 36 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021765
Page 37 of 158
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021766
Page 38 of 158
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021767
Page 39 of 158
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021768
Page 40 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021769
Page 41 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021770
Page 42 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure Durin
g Pregnancy Oct/19/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021771
Page 43 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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)[Exposure During Pregnancy]
4.Start Date Time: Oct/19/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021772
Page 44 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[N/A]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021773
Page 45 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021774
Page 46 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021775
Page 47 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021776
Page 48 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021777
Page 49 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021778
Page 50 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021779
Page 51 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021780
Page 52 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021781
Page 53 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021782
Page 54 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021783
Page 55 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021784
Page 56 of 158
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021785
Page 57 of 158
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021786
Page 58 of 158
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021787
Page 59 of 158
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021788
Page 60 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021789
Page 61 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021790
Page 62 of 158
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021791
Page 63 of 158
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021792
Page 64 of 158
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021793
Page 65 of 158
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021794
Page 66 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021795
Page 67 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021796
Page 68 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021797
Page 69 of 158
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021798
Page 70 of 158
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021799
Page 71 of 158
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021800
Page 72 of 158
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021801
Page 73 of 158
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021802
Page 74 of 158
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021803
Page 75 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021804
Page 76 of 158
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021805
Page 77 of 158
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021806
Page 78 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-02-2020 17:42:31 (UTC-06:00)
Central Time (US & Canada)Katherine
Benitez
(pfe.kbenitez)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021807
Page 79 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-02-2020 17:43:19 (UTC-06:00)
Central Time (US & Canada)Katherine
Benitez
(pfe.kbenitez)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021808
Page 80 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-24-2020 14:54:13 (UTC-06:00)
Central Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021809
Page 81 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-03-2021 13:41:19 (UTC-06:00)
Central Time (US & Canada)Chyann
Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021810
Page 82 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-03-2021 13:41:19 (UTC-06:00)
Central Time (US & Canada)Chyann
Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021811
Page 83 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-03-2021 13:41:37 (UTC-06:00)
Central Time (US & Canada)Chyann
Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021812
Page 84 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-03-2021 13:41:37 (UTC-06:00)
Central Time (US & Canada)Chyann
Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021813
Page 85 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Chyann
Stewart N/A Mar-03-2021 13:41:09 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory
Fuller Approved Jan-21-2021 14:07:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Claudia
Alonzo N/A Dec-14-2020 12:01:03 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021814
Page 86 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
N/A
Gregory
Fuller Approved Dec-10-2020 16:19:52 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Banika
Ervin N/A Nov-23-2020 16:48:05 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory
Fuller Approved Nov-03-2020 09:39:44 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021815
Page 87 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021816
Page 88 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020
17:40:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020
17:40:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021817
Page 89 of 158
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
17:40:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/2/2020Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021818
Page 90 of 158
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
17:40:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10851246Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
17:40:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
17:40:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021819
Page 91 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020
17:40:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
17:40:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
WHITEInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021820
Page 92 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020
17:42:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021821
Page 93 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020
17:43:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
17:43:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
17:43:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021822
Page 94 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
247.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021823
Page 95 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.7Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.4Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021824
Page 96 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
FInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021825
Page 97 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
17:44:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021826
Page 98 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021827
Page 99 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021828
Page 100 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-02-2020
17:44:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021829
Page 101 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
17:45:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
17:45:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
78304Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021830
Page 102 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
09:33:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
09:33:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
09:34:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
09:33:48
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021831
Page 103 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
09:33:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
09:34:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BP5BL
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
09:34:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BP5BLNInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021832
Page 104 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-03-2020
09:34:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BNVT6
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
09:34:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BNVT60Initial Entry
5.c
Date Location User Value Reason
Sep-03-2020
09:34:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BNVT6
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
09:34:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BNVT61Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021833
Page 105 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
09:33:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
09:33:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
09:34:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
09:33:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021834
Page 106 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
09:33:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
09:34:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BP5BJ6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
09:34:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BP5BJ6Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021835
Page 107 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021836
Page 108 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/2/2020 14:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021837
Page 109 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
17:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021838
Page 110 of 158
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
17:46:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021839
Page 111 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
12:25:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sep/25/2020Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021840
Page 112 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.1
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
1Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021841
Page 113 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
12:26:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021842
Page 114 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021843
Page 115 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021844
Page 116 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020
12:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021845
Page 117 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
12:25:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
12:25:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
12:25:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
12:25:34
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021846
Page 118 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
12:25:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
12:25:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BP9N88Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
12:25:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BP9N88Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021847
Page 119 of 158
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021848
Page 120 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sep/25/2020 12:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021849
Page 121 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-25-2020
12:28:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
YESInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021850
Page 122 of 158
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
11:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Oct/27/2020Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021851
Page 123 of 158
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020
11:41:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
11:41:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020
11:41:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
11:41:03
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021852
Page 124 of 158
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-27-2020
11:41:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
11:41:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BNZKP
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
11:41:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BNZKP3Initial Entry
5.b
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021853
Page 125 of 158
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Oct-27-2020
11:41:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BS7W2
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020
11:41:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BS7W2PInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020
11:41:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Sample ID
:BS7W2
RInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020
11:41:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
BS7W2RInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021854
Page 126 of 158
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020
11:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020
11:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020
11:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021855
Page 127 of 158
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Form Created
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021856
Page 128 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021
11:58:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Jan-05-2021
11:22:25
(UTC-06:00)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Query 2: Answere
dFaxed
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021857
Page 129 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time (US
& Canada)
Dec-22-2020
10:31:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL -
please submit a
Pregnancy
update with
Father
information
(age;
smoke/alcohol
/illicit drugs)
Dec-06-2020
09:03:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Dec-03-2020
16:17:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 1: Answere
dCorrect as
entered per
reported by
patient.
Dec-01-2020
14:22:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL Per
SAE meds
section, subj
had 1 cycle of
Loestrin,
ending
16OCT20 (with
LMP starting
19OCT20).
Prev birth
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021858
Page 130 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
control Yaz
reported to end
in ??OCT;
however, please
clarify if the
Yaz end date
(2nd to last
cycle) would be
in SEP2020.
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
Exposure During
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-30-2021
22:19:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed PG reported
onset of
19Oct20
Jan-18-2021
14:37:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Claudia
Alonzo
(pfe.calonzo)Query 4: Answer
edOriginal value is
correct
Jan-14-2021
22:54:16
(UTC-06:00)
Central TimeACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Reissue
d:OpenedClinical Thank
you; however
the most recent
PG report
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021859
Page 131 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada) update
(09Jan21) still
has PG start date
of 16Nov20.
Please submit an
updated start
date in the Event
section of the
report under
Start Date/Time.
Jan-13-2021
11:28:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Query 4: Answer
edThat date is
incorrect and
was corrected in
the Pregnancy
forms sent this
month.
Jan-11-2021
19:21:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Reissue
d:OpenedClinical Thank
you. Query
refers to the
Event Start date,
which is
19Oct20 on this
AE CRF log.
Pregnancy
report
(#2020459211)
still has the
16Nov20 start
date for the
pregnancy, not
19Oct20
Jan-08-2021 ACV0PFEINFP6000  Angi Cox Query 4: Answer This is not
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021860
Page 132 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
12:22:29
(UTC-06:00)
Central Time
(US & Canada)(pfe.acox1) ed correct. The
follow up form
sent on
06Jan2021
clearly shows
last LMP was
19Oct2020.
16Nov2020 was
the date of the
ultrasound.
Jan-08-2021
11:57:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened Clinical Event
start date is 1st
day of LMP
(18Oct20);
however, SAE
report (update
06Jan21) has a
different date of
16Nov20. Please
update SAE
report with 1st
day of LMP in
event section at
ONSET date, if
appropriate.
Jan-08-2021
11:52:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response
satisfies query
Jan-05-2021
11:26:38ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answer
edTranscription
Error
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021861
Page 133 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00)
Central Time
(US & Canada)
Jan-05-2021
11:26:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Angi Cox
(pfe.acox1)Data Entry:
Oct/19/2020 UN
K:UNKTranscription
Error
Dec-15-2020
12:33:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissue
d:OpenedCLINICAL Per
CRF completion
guidelines either
1st day of LMP
(19Oct20) or
estimated date
of conception by
ultrasound are
used for Start
date. As
16Nov20 is the
date of + urine
PG test (NOT
used), please
update to
previous 1st day
of LMP in both
AE & SAE.
Dec-14-2020
15:03:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answer
edChanged
Information
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021862
Page 134 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Dec-14-2020
15:03:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Claudia
Alonzo
(pfe.calonzo)Data Entry:
Nov/16/2020 UN
K:UNKChanged
Information
Dec-14-2020
13:45:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical Start
date of event is
19Oct20 (1st
day of LMP);
however, SAE
event start date
is 16Nov20.
Please review,
harmonize
reporting and
update in the
appropriate
location.
Dec-14-2020
13:37:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Dec-14-2020
12:01:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answer
edChanged
Information
Dec-14-2020
12:01:03
(UTC-06:00)ACV0PFEINFP6000  Claudia
Alonzo
(pfe.calonzo)Data Entry:
Oct/19/2020 UN
K:UNKChanged
Information
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021863
Page 135 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Central Time
(US & Canada)
Dec-10-2020
10:24:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissue
d:OpenedCLINICAL - per
C4591001
pregnancy
reporting
guideline Inj #1
on 02Sep and
either
conception or
1st day of LMP
date falling after
02Sep, makes
start of
Exposure the
latter date. In the
SAE this date is
19Oct20; please
harmonize on
AE CRF
Dec-07-2020
09:06:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Nov/16/2020 UN
K:UNKChanged
Information
Dec-07-2020
08:37:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Claudia
Alonzo
(pfe.calonzo)Query 2: Answer
edPositive
pregnancy test
was received on
16Oct2020 so
date of known
exposure would
be 16Oct2020.
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021864
Page 136 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
start date
updated to
16Oct2020
Dec-06-2020
09:11:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissue
d:OpenedCLINICAL
SAE report
states the 1st
day of last
menstrual period
was 19Oct20,
which per CRF
completion
guidelines can
be used as start
of PG; please
update start in
AE and SAE.
(Note urine PG
test was + on
16Nov20 per
SAE)
Dec-04-2020
12:21:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Data Entry:
Oct/16/2020 UN
K:UNKChanged
Information
Dec-04-2020
12:21:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
Benitez
(pfe.kbenitez)Query 2: Answer
edPositive
pregnancy test
was received on
16Oct2020 so
date of known
exposure would
be 16Oct2020.
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021865
Page 137 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
start date
updated to
16Oct2020
Dec-01-2020
14:15:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL
Event of
Exposure during
PG start date is
19OCT20;
however, the
start date in the
SAE report is
still 16Nov2020.
Please update as
well with a SAE
safety update
Dec-01-2020
14:11:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Nov-27-2020
12:49:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edChanged per
query
Nov-27-2020
12:49:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
Oct/19/2020 UN
K:UNKChanged per
query
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021866
Page 138 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Nov-24-2020
22:41:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissue
d:OpenedClinical Per
recent all-site
communication,
the alternative
guidance for PG
Start date would
be the first day
of LMP
(19Oct2020).
Please review
and update start
date as
appropriate.
Nov-24-2020
14:56:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 1: Answer
ed6wks 5 days was
average
gestational age
given by
ultrasound but is
not accurate
based on first
day of LMP.
True gestational
age is and date
is unknown.
Nov-23-2020
17:50:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical - PG
start date
reported as
16Nov2020 [day
of + pregnancy
test]. However,
optimal dating
by OB US on
18Nov2020
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021867
Page 139 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
reports a 6 week
5 days
pregnancy per
the SAE
narrative. Please
review PG start
date and update
as appropriate.
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
Nov/16/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-24-2020
22:42:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Nov-24-2020
14:57:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 1: Answered Changed data
per query
Nov-23-2020
17:36:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL -
Reporting
convention is
Not
Applicable for
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021868
Page 140 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
toxicity
grading for
pregnancy
reporting
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-24-2020
14:54:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
Not ApplicableInitial Entry
Nov-24-2020
14:54:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry: Transcription
Error
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021869
Page 141 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-24-2020
22:38:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Nov-24-2020
14:36:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dTranscription
Error
Nov-24-2020
14:36:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021870
Page 142 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-24-2020
14:36:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
NOTranscription
Error
Nov-23-2020
17:40:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL -
For standard
pregnancy
reporting,
reporting
convention is
Serious = NO.
Any
subsequent
complication
would undergo
a separate
assessment for
serious.
Nov-23-2020
16:48:05ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE
Exposure
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021871
Page 143 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00)
Central Time (US
& Canada)During
Pregnancy:
Response to
"Is the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?
NO
Did this serious
event result in de
ath?
NO
Did this serious
event require or
prolong hospitali
zation?
NOInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021872
Page 144 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Did this serious
event result in pe
rsistent or signifi
cant disability/in
capacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically
important seriou
s 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
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021873
Page 145 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Nov-24-2020
22:37:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Nov-24-2020
14:51:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Nov-24-2020
14:51:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, speci
fy:
N/ATranscription
Error
Nov-23-2020
17:46:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
Causality is
recorded as
RELATED in
AE CRF. Per
SAE report the
investigator
considered
there was NOT
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021874
Page 146 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
a reasonable
possibility that
exposure
during
pregnancy was
related to any
clinical trial
procedure.
Please update
as appropriate.
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021875
Page 147 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-24-2020
22:44:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Nov-24-2020
22:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Nov-24-2020
14:58:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 2: Answere
dCorrect as
entered
Nov-24-2020 ACV0PFEINFP6000  auto query Query 2: Opened For AE
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021876
Page 148 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
14:52:21
(UTC-06:00)
Central Time (US
& Canada)(autoquery) Exposure
During
Pregnancy:
Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End Date/Time
is provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Nov-24-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dChanged
Information
Nov-24-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
UNKNOWNChanged
Information
Nov-24-2020
11:25:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Per
CRF
Completion
Guidelines
section
8.50.2.5, the
outcome for an
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021877
Page 149 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
event of
Exposure
during
Pregnancy is
UNKNOWN
(until end of
pregnancy).
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Data Entry:
NOT RECOVER
ED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020
16:48:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021878
Page 150 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021
13:41:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
Jan/19/2021Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021879
Page 151 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-03-2021
13:42:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible per other
protocol allowanc
e(s) and confirme
d to have received
only placebo at V
accination 1/2Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021880
Page 152 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-03-2021
13:41:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-03-2021
13:41:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021881
Page 153 of 158
***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, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Mar-03-2021
13:41:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021882
Page 154 of 158
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-03-2021
13:41:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Chyann
Stewart
(pfe.cstewart)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021883
Page 155 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020
11:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020
17:45:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-02-2020
17:43:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-23-2020
17:52:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Query closed;
further
discussion of
start date on AE
CRF at event
start
Nov-23-2020 ACV0PFEINFP6000  Kathryn Query 1: Closed Response
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021884
Page 156 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
17:51:44
(UTC-06:00)
Central Time (US
& Canada)Sewell
(pfe.sewelk02)satisfies query
Nov-23-2020
16:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 1: Answere
dData entered
Nov-23-2020
12:12:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Banika Ervin
(pfe.bervin)Query 2: Answere
d16Nov2020 is
the date patient
first discovered
pregnancy so
that is the start
date given by
patient
Nov-20-2020
11:28:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL
Exposure
during PG start
date reported on
16Nov20 (+ PG
test date) in
SAE; however;
most accurate
test is Gyn
Ultrasound
which had 6
wks/5 days
pregnancy on
18Nov20.
Please review,
and update
event start date.
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021885
Page 157 of 158
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Nov-20-2020
11:26:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
Exposure
during
Pregnancy form
(#2020459211)
received;
however, no
event has been
entered on the
AE CRF; please
update.
Oct-27-2020
11:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-02-2020
17:45:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-02-2020
17:43:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021886
Page 158 of 158
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851246 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-28-2020
14:30:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Alicia
Cruz
(pfe.acruz)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d8d\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0021887