125742 S1 M5 CRF c4591001 1112 11121255

Document text

Page 1 of 201
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791406
Page 2 of 201
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/6/2020
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791407
Page 3 of 201
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11121255]
2.Birth Date: 1955
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791408
Page 4 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791409
Page 5 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791410
Page 6 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791411
Page 7 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1970
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Postmenopausal]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791412
Page 8 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Ovarian Cysts]
Start Date: UNK/UNK/1984
Ongoing: NO
End Date:
UNK/UNK/1984
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: UNK/UNK/1984
Ongoing: NO
End Date:
UNK/UNK/1984
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791413
Page 9 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791414
Page 10 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
2.Weight: [114.4]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [21.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791415
Page 11 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791416
Page 12 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/6/2020
2.Randomization Number: [257794]
3.Randomization Group: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791417
Page 13 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXRZB]
5.bSample ID [BPXRZC]
5.cSample ID [BPXRZD]
5.dSample ID [BJ4PVV]
5.eSample ID [BJ4PVW]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791418
Page 14 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXRZV]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791419
Page 15 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/6/2020 10:38
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
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791420
Page 16 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791421
Page 17 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791422
Page 18 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791423
Page 19 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/26/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791424
Page 20 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BMB9NM]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791425
Page 21 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was
ObservedNot Done Comments
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791426
Page 22 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791427
Page 23 of 201
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791428
Page 24 of 201
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/23/2020
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 [BMB9TL]
5.bSample ID [BMPDCW]
5.cSample ID [BMPDCX]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791429
Page 25 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791430
Page 26 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791431
Page 27 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791432
Page 28 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791433
Page 29 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791434
Page 30 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791435
Page 31 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791436
Page 32 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791437
Page 33 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791438
Page 34 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791439
Page 35 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791440
Page 36 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791441
Page 37 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791442
Page 38 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791443
Page 39 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791444
Page 40 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791445
Page 41 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791446
Page 42 of 201
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791447
Page 43 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Fever  Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:U
NK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Chills  Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:U
NK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Headache
s Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:U
NK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Muscle A
ches Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791448
Page 44 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Fever]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791449
Page 45 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791450
Page 46 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791451
Page 47 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chills]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791452
Page 48 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791453
Page 49 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791454
Page 50 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Headaches]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791455
Page 51 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791456
Page 52 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791457
Page 53 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Muscle Aches]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791458
Page 54 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791459
Page 55 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791460
Page 56 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791461
Page 57 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791462
Page 58 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791463
Page 59 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791464
Page 60 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791465
Page 61 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791466
Page 62 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791467
Page 63 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791468
Page 64 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791469
Page 65 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791470
Page 66 of 201
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791471
Page 67 of 201
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791472
Page 68 of 201
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791473
Page 69 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791474
Page 70 of 201
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791475
Page 71 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791476
Page 72 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791477
Page 73 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791478
Page 74 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791479
Page 75 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791480
Page 76 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791481
Page 77 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791482
Page 78 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791483
Page 79 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791484
Page 80 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791485
Page 81 of 201
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791486
Page 82 of 201
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791487
Page 83 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/7/2020
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791488
Page 84 of 201
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791489
Page 85 of 201
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nathan
Segall Approved Mar-06-2021 10:11:10 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791490
Page 86 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-06-2020 11:49:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791491
Page 87 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after
first vaccine and per PI will not
receive Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791492
Page 88 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791493
Page 89 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791494
Page 90 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791495
Page 91 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791496
Page 92 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791497
Page 93 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791498
Page 94 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791499
Page 95 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791500
Page 96 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791501
Page 97 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
10Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791502
Page 98 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
11Oct-26-2020 15:09:36 (UTC-05:00)
Eastern Time (US & Canada)subject had severe reactions after first
vaccine and per PI will not receive
Vaccine 2
Not Done
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791503
Page 99 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nathan
Segall Approved Mar-06-2021 10:11:10 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
 N/A Feb-25-2021 14:35:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan
Segall Approved Dec-22-2020 13:53:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791504
Page 100 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, NathanSegall, 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.
 N/A Dec-17-2020 13:44:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan
Segall Approved Nov-24-2020 16:07:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791505
Page 101 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
 N/A Nov-23-2020 14:09:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan
Segall Approved Nov-14-2020 08:48:49 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
 N/A Nov-11-2020 11:06:00 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan
Segall Approved Nov-10-2020 16:04:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791506
Page 102 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, NathanSegall, 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.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791507
Page 103 of 201
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-06-2020
11:48:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-06-2020
11:48:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791508
Page 104 of 201
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-06-2020
11:48:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/6/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791509
Page 105 of 201
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020
11:48:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11121255Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-06-2020
11:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-06-2020
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791510
Page 106 of 201
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-06-2020
11:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791511
Page 107 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
11:49:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791512
Page 108 of 201
***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, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-06-2020
11:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020
11:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020
11:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791513
Page 109 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Oct-06-2020
11:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Hypothy
roidism
Start Date: UNK/U
NK/197
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-06-2020
11:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020
11:50:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791514
Page 110 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-06-2020
11:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-06-2020
11:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-06-2020
13:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Postmen
opausal
Start Date: UNK/U
NK/199
5
Ongoing: YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791515
Page 111 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Oct-06-2020
13:36:56
(UTC-05:00)
Eastern 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-06-2020
13:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PostmenopausalInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-06-2020
13:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-06-2020
13:36:56ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791516
Page 112 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Oct-06-2020
13:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Anxiety
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791517
Page 113 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Oct-06-2020
13:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020
13:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-06-2020
13:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-06-2020
13:37:08ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791518
Page 114 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Oct-06-2020
13:37:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:Ovarian C
ysts
Start Date
:UNK/UN
K/1984
Ongoing: NO
End Date
:
UNK/U
NK/198
4Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791519
Page 115 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Oct-06-2020
13:37:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020
13:37:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Ovarian CystsInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-06-2020
13:37:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-06-2020
13:37:32ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791520
Page 116 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1984
1.e
Date Location User Value Reason
Oct-06-2020
13:37:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Hysterecto
my
Start Date
:UNK/UN
K/1984
Ongoing: NO
End Date
:
UNK/U
NK/198
4Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791521
Page 117 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Oct-06-2020
13:37:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020
13:37:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HysterectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-06-2020
13:37:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-06-2020
13:37:49ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791522
Page 118 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1984
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791523
Page 119 of 201
***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, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-06-2020
11:51:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791524
Page 120 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
114.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791525
Page 121 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.6Initial Entry
7.a
Date Location User Value Reason
Oct-06-2020
12:12:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:97.5Transcription
Error
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791526
Page 122 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:97.0
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-06-2020
12:12:42
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
97.5Transcription
Error
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791527
Page 123 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-06-2020
11:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791528
Page 124 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020
11:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-06-2020
11:57:50
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of
collection is
reported, but
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791529
Page 125 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)result is
missing.
Please review
and update as
appropriate.
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791530
Page 126 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
11:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor
-Defined
Identifie
r:113
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::NOT DO
NEInitial Entry
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor
-Defined
Identifie
r:
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-06-2020
11:58:02
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791531
Page 127 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
6.a Test:
Date Location User Value Reason
Oct-06-2020
11:57:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-06-2020
11:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791532
Page 128 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-06-2020
11:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-06-2020
11:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
257794Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791533
Page 129 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
11:58:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
11:58:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
11:58:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
11:58:33
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791534
Page 130 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
11:58:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
11:58:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXRZ
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
11:58:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXRZBInitial Entry
5.b
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791535
Page 131 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-06-2020
11:58:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXRZ
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020
11:58:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXRZCInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020
11:59:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXRZ
DInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791536
Page 132 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Oct-06-2020
11:59:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXRZDInitial Entry
5.d
Date Location User Value Reason
Oct-06-2020
11:59:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BJ4PV
VTranscription
Error
Oct-06-2020
11:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BJ4P
VInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791537
Page 133 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Oct-06-2020
11:59:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-06-2020
11:59:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BJ4PVVTranscription
Error
Oct-06-2020
11:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Oct-06-2020
11:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BJ4PVInitial Entry
5.e
Date Location User Value Reason
Oct-06-2020
12:00:00
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sample I
D:BJ4PV
WInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791538
Page 134 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
5.e Sample ID
Date Location User Value Reason
Oct-06-2020
12:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BJ4PVWInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791539
Page 135 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
12:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
12:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
12:01:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
12:00:40
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791540
Page 136 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
12:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
12:01:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXRZ
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
12:01:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXRZVInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791541
Page 137 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791542
Page 138 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 10:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791543
Page 139 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020
12:01:26
(UTC-05:00)
Eastern 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-06-2020
12:01:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791544
Page 140 of 201
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-06-2020
12:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791545
Page 141 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020
15:06:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791546
Page 142 of 201
***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, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2.a
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791547
Page 143 of 201
***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, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-26-2020
15:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791548
Page 144 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791549
Page 145 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791550
Page 146 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-26-2020
15:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791551
Page 147 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020
15:07:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020
15:07:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020
15:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-26-2020
15:07:22
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791552
Page 148 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-26-2020
15:07:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020
15:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMB9N
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020
15:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB9NMInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791553
Page 149 of 201
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791554
Page 150 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791555
Page 151 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
8. Actual Dose:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-26-2020
15:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-26-2020
15:09:36ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791556
Page 152 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791557
Page 153 of 201
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020
14:09:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791558
Page 154 of 201
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020
14:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020
14:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020
14:09:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-23-2020
14:09:12
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791559
Page 155 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-23-2020
14:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/23/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020
14:09:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMB9T
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-23-2020
14:09:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMB9TLInitial Entry
5.b
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791560
Page 156 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Nov-23-2020
14:09:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMPDC
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-23-2020
14:09:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMPDCWInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020
14:09:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMPDC
XInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791561
Page 157 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Nov-23-2020
14:09:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMPDCXInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791562
Page 158 of 201
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791563
Page 159 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791564
Page 160 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791565
Page 161 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791566
Page 162 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern 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
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791567
Page 163 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-27-2020
07:35:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as per
site response.
Oct-26-2020
15:12:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dexact time
unknown, but
progress note
states within 5
hrs
post-vaccine
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Fever:
Start Date is
the same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020
15:11:36ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791568
Page 164 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)End Date Time:
Oct/7/2020 UNK:
UNK
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern 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.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791569
Page 165 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
08:41:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per email
11/15/2020
query not
needed
Nov-15-2020
11:43:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly 1 AE
should have
DRUG
WITHDRAWN
as Action Taken.
Please have the
PI decide which
one is most
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791570
Page 166 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
appropriate.
Nov-11-2020
17:04:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:CandidateDM: Do not
issue query.
Sending to Triad
team for CRA
assistance.
Nov-11-2020
11:04:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPer PI note,
subject
withdrew due to
combination of
reactions.
Nov-11-2020
10:25:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly one
primary Adverse
Event should be
chosen. Multiple
are selected at
this time, please
select ONLY
Primary Adverse
Event.
Nov-11-2020
08:31:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edIt was a
combination of
all reactions
Nov-10-2020
22:22:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Only one
primary Adverse
Event should be
chosen to have
question
'LATEST
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791571
Page 167 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
ACTION
TAKEN WITH
STUDY DRUG'
that would
indicate DRUG
WITHDRAWN.
Multiple are
selected at this
time, please
select ONLY
Primary Adverse
Event.
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDR
AWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020
15:11:36ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791572
Page 168 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020
15:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791573
Page 169 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ChillsInitial Entry
4. Start Date Time:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791574
Page 170 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-27-2020
07:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Closed as per
site response.
Oct-26-2020
15:13:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dexact time is
not known,
but reported
post
vaccination
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Chills:
Start Date is
the same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791575
Page 171 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791576
Page 172 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
08:41:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per email
11/15/2020
query not
needed
Nov-15-2020
11:43:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly 1 AE
should have
DRUG
WITHDRAWN
as Action Taken.
Please have the
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791577
Page 173 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
PI decide which
one is most
appropriate.
Nov-11-2020
17:04:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:CandidateDM: Do not
issue query.
Sending to Triad
team for CRA
assistance.
Nov-11-2020
11:05:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPer PI note,
subject
withdrew due to
combination of
reactions.
Nov-11-2020
10:25:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly one
primary Adverse
Event should be
chosen. Multiple
are selected at
this time, please
select ONLY
Primary Adverse
Event.
Nov-11-2020
08:31:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edIt was a
combination of
all reactions
Nov-10-2020
22:22:47
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 1: Opened Only one
primary Adverse
Event should be
chosen to have
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791578
Page 174 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada) question
'LATEST
ACTION
TAKEN WITH
STUDY DRUG'
that would
indicate DRUG
WITHDRAWN.
Multiple are
selected at this
time, please
select ONLY
Primary Adverse
Event.
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDR
AWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791579
Page 175 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020
15:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791580
Page 176 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-01-2020
19:41:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-29-2020
10:36:46ACV0PFEINFP6000  Query 1: Answered confirm, no
history of
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791581
Page 177 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)headaches or
migraines or
cluster
headacheas
Oct-28-2020
21:36:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Headache:
Please confirm
that the
participant
does or does
not have a
prior medical
history of
migraine or
cluster
headaches
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadachesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020
07:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Closed as per
site response.
Oct-26-2020
15:14:30ACV0PFEINFP6000  Query 1: Answere
dexact time
unknown,
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791582
Page 178 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)reported post
vaccine
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Headaches:
Start Date is
the same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791583
Page 179 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern 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
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791584
Page 180 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
08:41:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per email
11/15/2020
query not
needed
Nov-15-2020
11:43:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly 1 AE
should have
DRUG
WITHDRAWN
as Action Taken.
Please have the
PI decide which
one is most
appropriate.
Nov-11-2020
17:04:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:CandidateDM: Do not
issue query.
Sending to Triad
team for CRA
assistance.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791585
Page 181 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-11-2020
11:05:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPer PI note,
subject
withdrew due to
combination of
reactions.
Nov-11-2020
10:26:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedOnly one
primary Adverse
Event should be
chosen. Multiple
are selected at
this time, please
select ONLY
Primary Adverse
Event.
Nov-11-2020
08:31:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edIt was a
combination of
all reactions
Nov-10-2020
22:23:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Only one
primary Adverse
Event should be
chosen to have
question
'LATEST
ACTION
TAKEN WITH
STUDY DRUG'
that would
indicate DRUG
WITHDRAWN.
Multiple are
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791586
Page 182 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
selected at this
time, please
select ONLY
Primary Adverse
Event.
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDR
AWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791587
Page 183 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020
15:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791588
Page 184 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle AchesInitial Entry
4. Start Date Time:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791589
Page 185 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Nov-06-2020
05:53:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-05-2020
08:03:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered confirm, post
vaccination,
exact time
unknown
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Muscle Aches:
Start Date is
the same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791590
Page 186 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791591
Page 187 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
08:02:51ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791592
Page 188 of 201
***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, Locked, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
08:02:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791593
Page 189 of 201
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020
15:41:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Nov-11-2020
11:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dchanged per
query
Nov-11-2020
11:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020changed per
query
Nov-11-2020
10:23:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissued
:OpenedThe page has
been unfrozen.
Please update
the date.
Nov-11-2020
08:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answere
dunable to
update, page is
locked
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791594
Page 190 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-10-2020
22:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened The
discontinuation
date of
26OCT2020
should be
relative to the
AE causing the
the withdrawal
of the study
vaccine, AE
start
06OCT2020 and
end 07OCT2020
(date should not
be after the AE
ended). Please
adjust
Discontinuation
date.
Oct-29-2020
20:51:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-28-2020
08:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dconfirm, subject
called before her
visit 2 to inform
us she did not
want to get the
second vaccine
due to her
adverse
reactions at
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791595
Page 191 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
vaccine 1
Oct-27-2020
22:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
subject has 3
AE's which lead
to withdrawal
from
vaccination on
07 Oct,
however, the
EOT page states
subject was
withdrawn on 26
Oct. please
review/update as
appropriate.
Thanks
Oct-26-2020
15:10:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020
15:10:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791596
Page 192 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-29-2020
00:10:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-27-2020
09:52:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dsubject is
continuing in
study, only
discontinued
from treatment
Oct-27-2020
07:39:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedDM: Per CRF
CR 8.55.2, If
Adverse Event
is primary
reason the
Participant was
discontinued
from study then
corresponding
AE should have
‘Did the
adverse event
cause the
Participant to
be discontinued
from the
study?" as Yes.
Please review
and update
CRF.
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791597
Page 193 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
15:16:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Oct-26-2020
15:16:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dnot
discontinued
from study but
from treatment
Oct-26-2020
15:10:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is
ADVERSE
EVENT but
"Specify
Status" is
Provided.
Oct-26-2020
15:10:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Status is
reported as
Adverse Event,
but there is no
Adverse Event
with 'Did the
adverse event
cause the
subject to be
discontinued
from the study'
reported as
YES. Please
check and
correct the
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791598
Page 194 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
data.
Oct-26-2020
15:10:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVE
NTInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-26-2020
15:16:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Oct-26-2020
15:10:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
due to severe reacti
ons to first vaccine,
subject did not rece
ive second vaccineInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791599
Page 195 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
14:35:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791600
Page 196 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-25-2021
14:35:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible and NOT
confirmed to have
received only plac
ebo at Vaccination
1/2Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791601
Page 197 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020
13:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-26-2021
01:51:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-25-2021
14:35:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answe
redChanged data per
query
Feb-25-2021
08:07:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissu
ed:OpenedPlease review and
complete the
REVAX CONT
visit.
Feb-24-2021 ACV0PFEINFP6000  Query 1: Answe unlock revax cont
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0791602
Page 198 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
20:06:48
(UTC-05:00)
Eastern Time
(US & Canada)red page for update
Feb-22-2021
22:27:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Katherine Puig Query 1: Opene
dDM: Primary
Reason for
Unblinding is
"ASSESS
ELIGIBILITY
FOR
ADDITIONAL
VACCINATION",
but "Participant is
willing to return
for Vaccination 3"
is not selected in
the Further
Vaccination
Confirmation
CRF. Please
review and update
as appropriate.
Dec-17-2020
13:44:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGI
BILITY FOR A
DDITIONAL V
ACCINATIONInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0791603
Page 199 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020
15:10:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-06-2020
11:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-06-2020
11:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020
11:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020changed per
query
Oct-26-2020
15:10:03ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791604
Page 200 of 201
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-06-2020
11:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Oct-06-2020
11:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791605
Page 201 of 201
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121255 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-09-2020
15:16:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3dfe\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791606