125742 S1 M5 CRF c4591001 1047 10471318

Document text

Page 1 of 147
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913370
Page 2 of 147
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/14/2020
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913371
Page 3 of 147
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10471318]
2.Birth Date: /1991
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913372
Page 4 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913373
Page 5 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913374
Page 6 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913375
Page 7 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[c section]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[c section]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913376
Page 8 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913377
Page 9 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [240.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [32.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913378
Page 10 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
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:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913379
Page 11 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [107233]
3.Randomization Group: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913380
Page 12 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8FNF]
5.bSample ID [BR8FNG]
5.cSample ID [BR8FNH]
5.dSample ID [BSHNW1]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913381
Page 13 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8FMW]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913382
Page 14 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 10:42
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
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913383
Page 15 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913384
Page 16 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913385
Page 17 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913386
Page 18 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/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:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913387
Page 19 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/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 [BR8F9J]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913388
Page 20 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/2/2020 09:05
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
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913389
Page 21 of 147
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913390
Page 22 of 147
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
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 [BSHP60]
5.bSample ID [BPSY18]
5.cSample ID [BPSY17]
5.dSample ID [BPSY16]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913391
Page 23 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913392
Page 24 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913393
Page 25 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913394
Page 26 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913395
Page 27 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913396
Page 28 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913397
Page 29 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913398
Page 30 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913399
Page 31 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913400
Page 32 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913401
Page 33 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913402
Page 34 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913403
Page 35 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913404
Page 36 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913405
Page 37 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913406
Page 38 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913407
Page 39 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure durin
g pregnancy Dec/UNK/202
0 UNK:UNK YES  Repeating
Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913408
Page 40 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Dec/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913409
Page 41 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[pregnancy]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913410
Page 42 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913411
Page 43 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913412
Page 44 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913413
Page 45 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913414
Page 46 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913415
Page 47 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913416
Page 48 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913417
Page 49 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913418
Page 50 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913419
Page 51 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913420
Page 52 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913421
Page 53 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913422
Page 54 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913423
Page 55 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913424
Page 56 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913425
Page 57 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913426
Page 58 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913427
Page 59 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913428
Page 60 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913429
Page 61 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913430
Page 62 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913431
Page 63 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913432
Page 64 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913433
Page 65 of 147
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913434
Page 66 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913435
Page 67 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913436
Page 68 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913437
Page 69 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913438
Page 70 of 147
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913439
Page 71 of 147
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913440
Page 72 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/30/2020
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913441
Page 73 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913442
Page 74 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913443
Page 75 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-14-2020 10:42:35 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913444
Page 76 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-18-2021 16:30:01 (UTC-06:00)
Central Time (US & Canada)Pregnancy not an Adverse event
Not Applicable
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913445
Page 77 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
 N/A Feb-11-2021 14:02:51 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 09:29:33 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913446
Page 78 of 147
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-14-2020
10:41:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020
10:41:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913447
Page 79 of 147
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020
10:42:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Oct/14/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913448
Page 80 of 147
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020
10:41:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10471318Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020
10:41:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1991Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020
10:42:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913449
Page 81 of 147
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020
10:42:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020
10:42:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913450
Page 82 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
10:42:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913451
Page 83 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-14-2020
10:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
10:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
10:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913452
Page 84 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020
12:09:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:c section
Start Date
:UNK/UN
K/2009
Ongoing: NO
End Date
:
UNK/U
NK/200
9Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020
12:09:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913453
Page 85 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-14-2020
12:09:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
c sectionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-14-2020
12:09:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020
12:09:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.b
Date Location User Value Reason
Oct-14-2020
12:09:59
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913454
Page 86 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada) Medical H
istory Ter
m:c section
Start Date
:UNK/UN
K/2010
Ongoing: NO
End Date
:
UNK/U
NK/201
0
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913455
Page 87 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020
12:09:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020
12:09:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
c sectionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020
12:09:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020
12:09:59ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913456
Page 88 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2010
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913457
Page 89 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-14-2020
12:09:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913458
Page 90 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
240.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913459
Page 91 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.5Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.7Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913460
Page 92 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913461
Page 93 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
12:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913462
Page 94 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913463
Page 95 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-14-2020
12:10:25
(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:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913464
Page 96 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-14-2020
12:10:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913465
Page 97 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020
12:08:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020
12:08:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
107233Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913466
Page 98 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
15:36:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
15:36:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
15:36:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
15:36:34
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913467
Page 99 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
15:36:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
15:36:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8FN
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
15:36:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8FNFInitial Entry
5.b
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913468
Page 100 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-14-2020
15:36:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8FN
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
15:36:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8FNGInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
15:37:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8FN
HInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913469
Page 101 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
15:37:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8FNHInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020
15:37:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSHN
W1Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
15:37:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHNW1Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913470
Page 102 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
11:32:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
11:32:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
11:32:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
11:32:39
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913471
Page 103 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
11:32:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
11:32:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR8FM
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
11:32:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8FMWInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913472
Page 104 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913473
Page 105 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020 10:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913474
Page 106 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-14-2020
12:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913475
Page 107 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-14-2020
10:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913476
Page 108 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020
10:39:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913477
Page 109 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
2.a
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.1
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913478
Page 110 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature:
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-02-2020
10:40:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913479
Page 111 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913480
Page 112 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-02-2020
10:40:21
(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:
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913481
Page 113 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-02-2020
10:40:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913482
Page 114 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020
12:01:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020
12:01:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
12:01:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-02-2020
12:01:35
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913483
Page 115 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-02-2020
12:01:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020
12:01:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR8F9
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020
12:01:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR8F9JInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913484
Page 116 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913485
Page 117 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020 09:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913486
Page 118 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-02-2020
10:40:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913487
Page 119 of 147
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020
08:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/30/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913488
Page 120 of 147
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020
15:45:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020
15:45:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-30-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-30-2020
15:45:39
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913489
Page 121 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-30-2020
15:45:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-30-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHP6
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-30-2020
15:45:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHP60Initial Entry
5.b
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913490
Page 122 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-30-2020
15:46:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPSY1
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-30-2020
15:46:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPSY18Initial Entry
5.c
Date Location User Value Reason
Nov-30-2020
15:47:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPSY1
7Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913491
Page 123 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Nov-30-2020
15:47:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPSY17Initial Entry
5.d
Date Location User Value Reason
Nov-30-2020
15:47:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPSY1
6Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-30-2020
15:47:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPSY16Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913492
Page 124 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913493
Page 125 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
15:23:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Closed Response
satisfies query
Mar-12-2021
08:56:40
(UTC-06:00)ACV0PFEINFP6000  Query 6: Answere
dIt was updated
to Exposure
during
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913494
Page 126 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)pregnancy under
item 10
Mar-11-2021
20:31:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Reissue
d:OpenedClinical - the
10Mar21 update
did not update
the event term,
which is still
Pregnancy.
Please update
event term to
match AE, per
CRF guidelines,
as Exposure
during
Pregnancy.
Mar-11-2021
07:52:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Answere
dThis was
submitted
yesterday
Mar-10-2021
20:39:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Reissue
d:OpenedClinical - no
medical records
are required for
EDP term,
which is already
reported on AE
CRF per study
guidelines.
Please simply
submit this same
updated term in
a PG safety
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913495
Page 127 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
update ASAP
Mar-09-2021
08:16:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Answere
dworking on
update waiting
on medical
records
Mar-09-2021
07:44:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed Response
satisfies query
Mar-09-2021
00:16:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Reissue
d:OpenedClinical - Please
send PG safety
update with
EDP term
ASAP
Mar-09-2021
00:15:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed;
will follow for
requested
Partner
information.
Mar-08-2021
11:35:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answere
dChanged data
per query
Mar-08-2021
11:35:23
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query 6: Answere
dworking on
update
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913496
Page 128 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Mar-08-2021
11:33:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answere
dworking on
update
Mar-05-2021
09:40:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 5: Closed reworded
Mar-05-2021
09:39:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Opened Clinical - Event
term is EDP;
however, PG
Safety report
(most recent
02Mar21) has
event term
Pregnancy.
Please submit a
PG Safety
update with
EDP term, per
reporting
guidelines
Mar-05-2021
09:37:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissue
d:OpenedClinical Please
try to contact
subject/partner
for this
interview before
the data lock in
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913497
Page 129 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
mid March
Mar-04-2021
17:35:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissue
d:OpenedClinical - start
date on AE CRF
is XX Nov
2020; however,
SAE report start
date is XX Dec
2020. Please
review,
harmonize
reporting, and
update where
applicable
Mar-04-2021
17:33:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 5: Opened Clinical Per
most recent PG
Safety report,
event term is
still Pregnancy.
Please update
event to EDP
per study
guidelines
Mar-04-2021
17:14:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-04-2021
07:46:18
(UTC-06:00)
Central TimeACV0PFEINFP6000  auto query
(autoquery)Query 4: Answere
dchanged per
query
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913498
Page 130 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Mar-04-2021
07:46:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answere
dchanged per
query
Mar-04-2021
07:46:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dchanged per
query
Mar-04-2021
07:46:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exposure during
pregnancychanged per
query
Mar-02-2021
11:18:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed;
will follow for
requested date
of urine PG test
information.
Mar-02-2021
11:11:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 4: Opened Clinical please
try to clarify the
PG event start
date (XX NOV
2020) if at all
possible to
clarify if this
occurred before
/ after VAX 2 on
02Nov2020
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913499
Page 131 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-02-2021
11:09:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissue
d:OpenedClinical Please
try to contact
subject/partner
for this
interview before
the data lock in
mid March
Mar-02-2021
11:07:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedClinical - PG
safety Event
term is
Exposure during
Pregnancy;
however, here
the event term is
still Pregnancy.
Please update to
EDP term per
study guidleines
Feb-26-2021
14:29:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dupdated per
query
Feb-26-2021
14:29:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Pregnancyupdated per
query
Feb-26-2021
14:27:49
(UTC-06:00)ACV0PFEINFP6000  Query 3: Answere
dwill update
when patient
calls back and I
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913500
Page 132 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)can interview
her
Feb-26-2021
14:27:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answere
dtrying to contact
subject to get
clarification on
these issues will
update when I
have the info
Feb-19-2021
00:18:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical Please
submit a PG
safety update to
report father
info (age, meds,
conditions,
social hx)
Feb-19-2021
00:15:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL Per
PG report
(#2021156268),
subject stated
she 'just had a
positive urine
pregnancy test'
before 11Feb21.
Please submit a
safety update to
report the
positive urine
pregnancy test
date. Also
submit
contraception
method in trial
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913501
Page 133 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& if using now
Feb-19-2021
00:12:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical - Event
term is
Exposure during
Pregnancy;
however, PG
Safety report
has event term
Pregnancy.
Please review
event term,
harmonize
reporting, and
update where
required.
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exposure During
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021
11:34:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2020 U
NK:UNKTranscription
Error
Mar-02-2021
11:08:11
(UTC-06:00)ACV0PFEINFP6000  Query 1: Closed Query closed;
will follow for
requested OB
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913502
Page 134 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)ultrasound
information.
Feb-26-2021
14:28:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dwill update
when I obtain
the information
Feb-19-2021
00:16:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical As
subject does
not recall the
1st day of last
menstrual
period, please
submit the
estimated
conception
date based on
OB ultrasound,
when available
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2020 U
NK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913503
Page 135 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021
16:30:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913504
Page 136 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
16:29:26
(UTC-06:00)
Central Time (US
& Canada)NO
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913505
Page 137 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
14:15:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913506
Page 138 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
13:40:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed UNKNOWN is
correctly reported
per CRF completion
GLs - no further
queries should be
issued. Thank you!
Mar-09-2021
08:16:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answe
redThis was changed to
unknown per query
instructions the
pregnancy is still
ongoing.
Mar-09-2021
08:13:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dFor AE 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".
Mar-09-2021
08:13:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redupdated per query
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913507
Page 139 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021
08:13:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNupdated per query
Mar-08-2021
22:28:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dSAE RECON:
AER#2021156268,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance ,
outcome should be
recorded as
UNKNOWN.
Please confirm and
update accordingly.
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021
16:29:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913508
Page 140 of 147
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-30-2020
08:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-30-2020
08:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-30-2020
08:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913509
Page 141 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
14:02:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913510
Page 142 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-11-2021
14:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-11-2021
14:02:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-11-2021
14:02:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per oth
er protocol allo
wance(s) and c
onfirmed to haInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913511
Page 143 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ve received onl
y placebo at Va
ccination 1/2
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913512
Page 144 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-11-2021
14:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-11-2021
14:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913513
Page 145 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-30-2020
08:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020
12:08:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-14-2020
10:42:49
(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-30-2020
08:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/30/2020Initial Entry
Oct-14-2020
12:08:13ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913514
Page 146 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Oct-14-2020
10:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913515
Page 147 of 147
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-21-2021
09:28:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3083\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0913516