125742 S1 M5 CRF c4591001 1112 11121118

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
182
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Document text

Page 1 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790892
Page 2 of 182
***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: 11121118 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
Aug/11/2020
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790893
Page 3 of 182
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11121118]
2.Birth Date: /1964
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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790894
Page 4 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790895
Page 5 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790896
Page 6 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790897
Page 7 of 182
***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: 11121118 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:[Partial Hysterectomy]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790898
Page 8 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [170.2]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [26.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790899
Page 9 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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: Aug/11/2020
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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790900
Page 10 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225807]
3.Randomization Group: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790901
Page 11 of 182
***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: 11121118 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:
Aug/11/2020
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 [BHX5VR]
5.bSample ID [BHX5VS]
5.cSample ID [BHX5VT]
5.dSample ID [BJ4P6G]
5.eSample ID [BJ4P6H]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790902
Page 12 of 182
***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: 11121118 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:
Aug/11/2020
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 [BHX613]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790903
Page 13 of 182
***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: 11121118 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: Aug/11/2020 14:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790904
Page 14 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790905
Page 15 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790906
Page 16 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790907
Page 17 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790908
Page 18 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790909
Page 19 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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: Sep/1/2020
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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790910
Page 20 of 182
***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: 11121118 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:
Sep/1/2020
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 [BHX6BW]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790911
Page 21 of 182
***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: 11121118 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 Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790912
Page 22 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790913
Page 23 of 182
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790914
Page 24 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790915
Page 25 of 182
***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: 11121118 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:
Sep/29/2020
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 [BPY02G]
5.bSample ID [BPY02H]
5.cSample ID [BPY02J]
5.dSample ID [BJ4PNF]
5.eSample ID [BJ4PNG]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790916
Page 26 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790917
Page 27 of 182
***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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790918
Page 28 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790919
Page 29 of 182
***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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790920
Page 30 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790921
Page 31 of 182
***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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790922
Page 32 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790923
Page 33 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11121118 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: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790924
Page 34 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790925
Page 35 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790926
Page 36 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11121118 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?
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790927
Page 37 of 182
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790928
Page 38 of 182
***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: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790929
Page 39 of 182
***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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790930
Page 40 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790931
Page 41 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: UNPLANNED VISIT
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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790932
Page 42 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/13/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIARY
3.Comments: [subject recorded severe muscle pain in error, should have been mild]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790933
Page 43 of 182
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Aug/12/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790934
Page 44 of 182
***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: 11121118 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: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790935
Page 45 of 182
***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: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790936
Page 46 of 182
***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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790937
Page 47 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Generalized Pruri
tus Aug/12/2020 UNK:U
NK NO
End Date Time:
Aug/12/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Tachycardia  Aug/12/2020 UNK:U
NK NO
End Date Time:
Aug/12/2020 UNK:UNK
 Repeating
Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790938
Page 48 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11121118 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)[Generalized Pruritus]
4.Start Date Time: Aug/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/12/2020 UNK:UNK
6.Toxicity Grade: 3
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
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790939
Page 49 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790940
Page 50 of 182
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11121118 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)[Tachycardia]
4.Start Date Time: Aug/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/12/2020 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790941
Page 51 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11121118 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[ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790942
Page 52 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790943
Page 53 of 182
***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: 11121118 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[ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790944
Page 54 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790945
Page 55 of 182
***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: 11121118 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: //
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790946
Page 56 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790947
Page 57 of 182
***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: 11121118 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?
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790948
Page 58 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790949
Page 59 of 182
***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: 11121118 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?
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790950
Page 60 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790951
Page 61 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790952
Page 62 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790953
Page 63 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790954
Page 64 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11121118 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:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790955
Page 65 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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?
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790956
Page 66 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790957
Page 67 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790958
Page 68 of 182
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790959
Page 69 of 182
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790960
Page 70 of 182
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790961
Page 71 of 182
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11121118 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 [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790962
Page 72 of 182
***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: 11121118 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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790963
Page 73 of 182
***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: 11121118 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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790964
Page 74 of 182
***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: 11121118 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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790965
Page 75 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790966
Page 76 of 182
***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: 11121118 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: [ ]
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790967
Page 77 of 182
***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: 11121118 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 Aug/12/2020
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790968
Page 78 of 182
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11121118 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
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790969
Page 79 of 182
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11121118 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-03-2021 21:03:01 (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.
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790970
Page 80 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-11-2020 16:13:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790971
Page 81 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790972
Page 82 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790973
Page 83 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790974
Page 84 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790975
Page 85 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790976
Page 86 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790977
Page 87 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790978
Page 88 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790979
Page 89 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790980
Page 90 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790981
Page 91 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
10Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790982
Page 92 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
11Sep-01-2020 18:23:30 (UTC-05:00) Eastern Time
(US & Canada)subject will not receive second vaccine due to
adverse after first vaccine
Not Done
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790983
Page 93 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790984
Page 94 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790985
Page 95 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790986
Page 96 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.bSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790987
Page 97 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.cSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790988
Page 98 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.dSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790989
Page 99 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.eSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790990
Page 100 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.fSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790991
Page 101 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.gSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790992
Page 102 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.hSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790993
Page 103 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790994
Page 104 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790995
Page 105 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790996
Page 106 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790997
Page 107 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cSep-29-2020 14:54:03 (UTC-05:00) Eastern Time
(US & Canada)vaccine not give at V2 due to AE at V1 vaccine
Not Applicable
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0790998
Page 108 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11121118 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-03-2021 21:03:01 (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 Mar-02-2021 11:06:09 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall  Approved Nov-16-2020 15:32:36 (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 11:03:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall  Approved Oct-09-2020 11:55:11 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790999
Page 109 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11121118 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 Sep-29-2020 14:53:37 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall  Approved Sep-10-2020 16:32:15 (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.
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791000
Page 110 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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
Aug-11-2020 16:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020 16:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791001
Page 111 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020 16:12:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/11/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791002
Page 112 of 182
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 01:44:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-18-2020 08:14:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-17-2020 09:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened PDQ: Requery: Thank
you for response. As
per section 8.43 of
CRF Completion
Requirements, please
consider updating
UNPLANNED VISIT
form and select the
appropriate Contact
Outcome option
present on
UNPLANNED VISIT
(UNPL) form.
Aug-14-2020 18:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered this was marked in
error, DCF submitted
Aug-14-2020 10:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Subject has
reported severe
symptoms/reaction in
eDiary data on
12Aug2020. Please
confirm if an
UNPLANNED contact
was made and update
the data as
appropriate.
Aug-11-2020 16:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11121118Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0791003
Page 113 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-11-2020 16:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 16:12:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 16:12:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020 16:12:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791004
Page 114 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-11-2020 16:13:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791005
Page 115 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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
Aug-11-2020 16:13:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020 16:13:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020 16:13:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791006
Page 116 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020 16:14:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Partial Hysterect
omy
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2
010Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:14:38
(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
Aug-11-2020 16:14:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Partial HysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020 16:14:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020 16:14:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3dcd\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-2021-5683-0791007
Page 117 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
UNK/UNK/2010
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791008
Page 118 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
170.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.7Initial Entry
7.a
090177e196ae3dcd\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-2021-5683-0791009
Page 119 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020 16:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dcd\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-2021-5683-0791010
Page 120 of 182
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791011
Page 121 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-11-2020 16:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791012
Page 122 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020 16:15:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020 16:15:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
225807Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791013
Page 123 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 17:11:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 17:11:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 17:11:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 17:11:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-11-2020 17:11:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 17:11:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHX5VRInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791014
Page 124 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-11-2020 17:11:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHX5VRInitial Entry
5.b
Date Location User Value Reason
Aug-11-2020 17:12:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHX5VSInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020 17:12:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHX5VSInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020 17:12:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHX5VTInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-11-2020 17:12:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHX5VTInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020 17:12:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ4P6GInitial Entry
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791015
Page 125 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Aug-11-2020 17:12:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BJ4P6GInitial Entry
5.e
Date Location User Value Reason
Aug-11-2020 17:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ4P6HInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-11-2020 17:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BJ4P6HInitial Entry
090177e196ae3dcd\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-2021-5683-0791016
Page 126 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 17:12:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 17:12:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 17:13:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 17:12:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-11-2020 17:12:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 17:13:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHX613Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791017
Page 127 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-11-2020 17:13:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHX613Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791018
Page 128 of 182
***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: 11121118 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
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020 14:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3dcd\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-2021-5683-0791019
Page 129 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-11-2020 16:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791020
Page 130 of 182
***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: 11121118 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
Sep-04-2020 08:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 2: Closed Response satisfies
query
Sep-04-2020 07:57:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered confirm, DCF was
submitted and issue
closed on 8/14/2020
Sep-04-2020 02:23:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CPG3- Please can
you confirm a DCF
will be submitted for
the incorrect diary
entry? Thanks
Sep-03-2020 16:07:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 2: Candidate CPG3- Please can
you confirm a DCF
will be submitted for
the incorrect diary
entry? Thanks
Aug-20-2020 18:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-19-2020 08:06:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-18-2020 21:04:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: per section 8.41
of ecrf completion
requirements, if a
subject has a severe
reaction they must be
contacted. As such,
this contact must be
documented in the
UNPL log and a
comment added to
state why a UNPL
visit will not occur.
please update. thanks
Aug-17-2020 07:53:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered patient reported
severe in error, she
had mild muscle pain
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0791021
Page 131 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-16-2020 20:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject reported:New
or Worsened Muscle
Pain Severity
(Severe) In the
e-diary on 11 Aug,
but no UNPL visit
has occurred. Please
can you confirm
subject has been
contacted? If so,
report in UNPL log.
Thanks
Aug-11-2020 16:16:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791022
Page 132 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 18:18:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791023
Page 133 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3dcd\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-2021-5683-0791024
Page 134 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791025
Page 135 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.d
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791026
Page 136 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae3dcd\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-2021-5683-0791027
Page 137 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791028
Page 138 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 18:21:00 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3dcd\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-2021-5683-0791029
Page 139 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00) Eastern Time
(US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791030
Page 140 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were injection site react
ions present on the last d
ay the Subject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 18:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791031
Page 141 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3dcd\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-2021-5683-0791032
Page 142 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-01-2020 18:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791033
Page 143 of 182
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791034
Page 144 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-01-2020 18:21:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791035
Page 145 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 18:22:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 18:22:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 18:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 18:22:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-01-2020 18:22:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 18:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHX6BWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791036
Page 146 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-01-2020 18:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHX6BWInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791037
Page 147 of 182
***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: 11121118 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
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791038
Page 148 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 18:23:30
(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
Sep-01-2020 18:23:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3dcd\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-2021-5683-0791039
Page 149 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 14:53:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791040
Page 150 of 182
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
eInitial Entry
090177e196ae3dcd\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-2021-5683-0791041
Page 151 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
e
2.b Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
090177e196ae3dcd\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-2021-5683-0791042
Page 152 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.c Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e
Date Location User Value Reason
090177e196ae3dcd\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-2021-5683-0791043
Page 153 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
090177e196ae3dcd\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-2021-5683-0791044
Page 154 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.f Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h
Date Location User Value Reason
090177e196ae3dcd\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-2021-5683-0791045
Page 155 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
AppliInitial Entry
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791046
Page 156 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
cable
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Appli
cable
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Appli
cableInitial Entry
090177e196ae3dcd\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-2021-5683-0791047
Page 157 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appli
cable
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Appli
cableInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 14:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3dcd\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-2021-5683-0791048
Page 158 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 14:54:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 14:54:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 14:54:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 14:54:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-29-2020 14:54:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 14:54:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY02GInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791049
Page 159 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020 14:54:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY02GInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 14:54:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY02HInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 14:54:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY02HInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 14:54:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY02JInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 14:54:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY02JInitial Entry
5.d
Date Location User Value Reason
Sep-29-2020 14:55:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ4PNFInitial Entry
090177e196ae3dcd\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791050
Page 160 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 14:55:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BJ4PNFInitial Entry
5.e
Date Location User Value Reason
Sep-29-2020 14:55:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ4PNGInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-29-2020 14:55:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BJ4PNGInitial Entry
090177e196ae3dcd\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-2021-5683-0791051
Page 161 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 08:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791052
Page 162 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: UNPLANNED VISIT - 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Assessments
Date Location User Value Reason
Aug-18-2020 08:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 08:13:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Aug-18-2020 08:13:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791053
Page 163 of 182
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-18-2020 08:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-18-2020 08:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Aug/13/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA
ENTRY ERROR IN E-DIARYInitial Entry
3. Comments:
Date Location User Value Reason
Aug-18-2020 08:14:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
subject recorded severe muscle pain
in error, should have been mildInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791054
Page 164 of 182
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 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
Aug-25-2020 09:14:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Transcription Error
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 03:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed site: subject remains
in study but treatment
is withdrawn
Aug-24-2020 09:24:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered subject remains in
study but treatment is
withdrawn
Aug-24-2020 09:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Aug-24-2020 09:23:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Aug-24-2020 09:22:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
090177e196ae3dcd\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-2021-5683-0791055
Page 165 of 182
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
adverse event cause
the subject to be
discontinued from
the study' reported as
YES. Please check
and correct the data.
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Aug-24-2020 09:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-24-2020 09:23:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
subject remains in study but treatme
nt is withdrawnInitial Entry
Aug-24-2020 09:22:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Treatment discontinuedInitial Entry
090177e196ae3dcd\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-2021-5683-0791056
Page 166 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791057
Page 167 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791058
Page 168 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Aug-17-2020 08:20:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed That query is not
visible for site
Aug-16-2020 00:46:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject is listed to
have Tachycardia and
generalised Pruritus
which led to the drug
being withdrawn,
however, the
disposition CRF is
not complete. Please
review and update as
appropriate.
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-13-2020 17:34:29
(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
Nov-14-2020 08:46:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-14-2020 08:38:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered confirm, related
Nov-14-2020 08:33:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical:
Thanks.Please also
confirm causality as
per protocol Section
10.3.3 considering
the time relationship
090177e196ae3dcd\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-2021-5683-0791059
Page 169 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
between vaccination
and AE start and the
associated AE
Nov-14-2020 08:20:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered confirm no associated
rash
Nov-13-2020 10:49:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls confirm
no associated rash, or
update CRF if
appropriate. Thanks
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Generalized PruritusInitial Entry
4. Start Date Time:
Date Location User ValueReason
Aug-25-2020
14:01:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_33
Aug-25-2020
09:25:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredupdated
Aug-25-2020
04:33:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4338327;The Latest
Action to Study Treatment
is DRUG WITHDRAWN,
but the Start Date of this AE
is AFTER the Date of
Completion/Discontinuation
/Death on Disposition-
Treatment Form. Please
review and update as
appropriate.
Aug-13-2020
17:34:29
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Data
Entry
:
Aug/1
2/202Initial Entry
090177e196ae3dcd\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)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0791060
Page 170 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada) 0 UN
K:UN
K
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-13-2020 17:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/12/2020 UNK:UNKTranscription Error
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-13-2020 17:34:29
(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
Aug-13-2020 17:34:29
(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
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3dcd\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-2021-5683-0791061
Page 171 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-13-2020 17:34:29
(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-11-2020 14:22:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-11-2020 11:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-11-2020 11:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEChanged Information
Nov-11-2020 10:28:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened page has been
unfrozen and
unlocked, please
update.
Nov-11-2020 08:28:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered unable to update,
page locked
Nov-10-2020 22:21:08
(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 selected
at this time, please
select ONLY Primary
Adverse Event.
Aug-13-2020 17:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3dcd\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), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791062
Page 172 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-13-2020 17:34:29
(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
Aug-13-2020 17:34:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 17:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Generalized
Pruritus: Response to "What
was the outcome of this
adverse event?" is
RECOVERED/RESOLVED
but End Date/Time is
missing.
Aug-13-2020 17:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-13-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791063
Page 173 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-13-2020 17:35:43
(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
Aug-25-2020 08:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-24-2020 09:23:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-21-2020 06:30:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened ClinQuery:please
review eCRF V5
section 8.53 regarding
disposition of
treatment. Please
update as appropriate.
thanks
Aug-20-2020 08:55:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject is withdrawn
from treatment, not
from study.
disposition is for
unblinding, consent
withdrawal or death.
Aug-19-2020 21:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened ClinQuery: please
review ecrf section
8.45.13 - if AE caused
subject to be
withdrawn, this
090177e196ae3dcd\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-2021-5683-0791064
Page 174 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
requires the
disposition CRF to be
complete. please
advise if unclear.
thanks
Aug-18-2020 08:12:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered disposition CRF does
not apply??
Aug-17-2020 08:21:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject is listed to
have Tachycardia and
generalised Pruritus
which led to the drug
being withdrawn,
however, the
disposition CRF is not
complete. Please
review and update as
appropriate.
Aug-13-2020 17:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TachycardiaInitial Entry
4. Start Date Time:
Date Location User ValueReason
Aug-25-2020
14:01:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_33
Aug-25-2020
09:25:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredupdated
Aug-25-2020
04:33:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4338328;The Latest
Action to Study Treatment
is DRUG WITHDRAWN,
but the Start Date of this AE
is AFTER the Date of
Completion/Discontinuation
/Death on Disposition-
Treatment Form. Please
090177e196ae3dcd\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) (4)
(b) (4)
FDA-CBER-2021-5683-0791065
Page 175 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
review and update as
appropriate.
Aug-13-2020
17:35:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Aug/1
2/202
0 UN
K:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-13-2020 17:35:43
(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
Aug-13-2020 17:35:43
(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
Aug-13-2020 17:35:43
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791066
Page 176 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Aug-13-2020 17:35:43
(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-11-2020 10:28:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-11-2020 08:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered value is correct
Nov-10-2020 22:21:30
(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 selected
at this time, please
select ONLY Primary
Adverse Event.
Aug-13-2020 17:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3dcd\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), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791067
Page 177 of 182
***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, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-13-2020 17:35:43
(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
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-13-2020 17:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3dcd\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-2021-5683-0791068
Page 178 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 11:39:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 11:39:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Transcription Error
Mar-02-2021 11:06:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Visit,
17/Dec/2021 is a
future date relative to
when it was entered
on 02/Mar/2021.
Please correct.
Mar-02-2021 11:06:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2021Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791069
Page 179 of 182
***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: 11121118 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
Mar-02-2021 11:06:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791070
Page 180 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-02-2021 11:06:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-02-2021 11:06:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791071
Page 181 of 182
***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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-11-2020 16:15:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-11-2020 16:13:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Aug-25-2020 09:14:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Transcription Error
Aug-24-2020 09:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-11-2020 16:15:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-11-2020 16:13:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
090177e196ae3dcd\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791072
Page 182 of 182
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11121118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-16-2020 15:30:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
Nov-16-2020 15:30:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-10-2020 10:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3dcd\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-2021-5683-0791073
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