Document text
Page 1 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843076
Page 2 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/10/2020
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843077
Page 3 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11621059]
2.Birth Date: 1959
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843078
Page 4 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843079
Page 5 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843080
Page 6 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843081
Page 7 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Type II]
Start Date: UNK/UNK/1999
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nearsighted]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843082
Page 8 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[smoking]
Start Date: Aug/10/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pneumonia ]
Start Date: Sep/3/2020
Ongoing: NO
End Date:
Sep/12/2020
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843083
Page 9 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/10/2020
2.Weight: [69.0]
3.Unit: kg
4.Height: [171.0]
5.Unit: cm
6.Body Mass Index: [23.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843084
Page 10 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/10/2020
2.Randomization Number: [224774]
3.Randomization Group: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843085
Page 11 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLNTD]
5.bSample ID [BPLNTF]
5.cSample ID [BP3CLN]
5.dSample ID [BP3CLP]
5.eSample ID [BP3CLR]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843086
Page 12 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3CLM]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843087
Page 13 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/10/2020 11:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843088
Page 14 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843089
Page 15 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843090
Page 16 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?YES
Ongoing?
NO
Stop Date:
Aug/18/2020
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843091
Page 17 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843092
Page 18 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843093
Page 19 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843094
Page 20 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8CS0]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843095
Page 21 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 11:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843096
Page 22 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843097
Page 23 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?YES
Ongoing?
NO
Stop Date:
Sep/12/2020
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843098
Page 24 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843099
Page 25 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843100
Page 26 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BLFV0H]
5.bSample ID [BR8S9M]
5.cSample ID [BLFV0J]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843101
Page 27 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843102
Page 28 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843103
Page 29 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843104
Page 30 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843105
Page 31 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843106
Page 32 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843107
Page 33 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843108
Page 34 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843109
Page 35 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843110
Page 36 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843111
Page 37 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843112
Page 38 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843113
Page 39 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843114
Page 40 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843115
Page 41 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/6/2020
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843116
Page 42 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843117
Page 43 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? NO
If No, why?
[Subject visited the hospital for unrelated illness. see SAE report
for symptoms]
3.Comments: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843118
Page 44 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843119
Page 45 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death //
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843120
Page 46 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843121
Page 47 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843122
Page 48 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ident
ifierAdverse
EventStart DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 pneumoni
a Sep/3/2020 UN
K UNK NO
End Date Time
Sep/13/2020 UNK:U
NK
Repeating
Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843123
Page 49 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
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)[pneumonia]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/13/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843124
Page 50 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital
anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
YES
Did this serious event result in persistent or
significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NOComments
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
OTHER
If Other, specify:
[unblinded per tx physician physician request
sponsor notify of unblinded]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843125
Page 51 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 WITH SEQUELAE Comments
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020345109]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843126
Page 52 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedication
ErrorStart D
ateIs the medication error
Still OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843127
Page 53 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843128
Page 54 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843129
Page 55 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843130
Page 56 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843131
Page 57 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843132
Page 58 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843133
Page 59 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843134
Page 60 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843135
Page 61 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843136
Page 62 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843137
Page 63 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843138
Page 64 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843139
Page 65 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843140
Page 66 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843141
Page 67 of 214
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843142
Page 68 of 214
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843143
Page 69 of 214
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843144
Page 70 of 214
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843145
Page 71 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843146
Page 72 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to return
for Vaccination 3?Not Applicable Comments
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843147
Page 73 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Sep/4/2020
2.Primary Reason for
Unblinding:SUBJECT SAFETY CONCERN
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843148
Page 74 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843149
Page 75 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843150
Page 76 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843151
Page 77 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Done Comments
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843152
Page 78 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843153
Page 79 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843154
Page 80 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843155
Page 81 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843156
Page 82 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843157
Page 83 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-10-2020 13:13:19 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843158
Page 84 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-16-2020 12:06:20 (UTC-05:00)
Eastern Time (US & Canada)Subject is still hospitalized, and has not
been discharged from the hospital yet.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843159
Page 85 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Sep-17-2020 15:04:21 (UTC-05:00)
Eastern Time (US & Canada)transcription error.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843160
Page 86 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
13Sep-16-2020 12:05:52 (UTC-05:00)
Eastern Time (US & Canada)Subject is still hospitalized, so as of now
we do not know the outcome. When, the
subject is discharged we will have more
information.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843161
Page 87 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-03-2021 12:17:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843162
Page 88 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION -
Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-03-2021 12:17:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843163
Page 89 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-29-2020 08:51:29 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843164
Page 90 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-29-2020 08:51:29 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843165
Page 91 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-29-2020 08:51:54 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843166
Page 92 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-29-2020 08:51:54 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843167
Page 93 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
- Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-09-2021 12:21:58 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843168
Page 94 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
- Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-09-2021 12:21:58 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843169
Page 95 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormFeb-26-2021 07:36:35 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843170
Page 96 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-09-2021 12:21:16 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843171
Page 97 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-09-2021 12:21:16 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843172
Page 98 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-09-2021 12:21:16 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843173
Page 99 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-09-2021 12:21:16 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843174
Page 100 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Mar-09-2021 12:21:16 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843175
Page 101 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-26-2021 07:33:27 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-05-2020 18:38:51 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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-03-2020 17:52:36 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-02-2020 09:09:02 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843176
Page 102 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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 Oct-29-2020 08:51:16 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Oct-21-2020 17:14:47 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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 Oct-06-2020 13:55:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843177
Page 103 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Robert
Riesenberg Approved Sep-22-2020 18:11:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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-22-2020 10:59:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Sep-18-2020 18:06:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843178
Page 104 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-10-2020
13:12:06
(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
Sep-22-2020
13:32:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response
satisfies query
Sep-22-2020
10:55:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Site unable to
get in touch
with subject to
schedule
COVID Illness
visit, site will
update data
when available
Sep-07-2020
14:16:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: The
subject has a
SAE of
“Pneumonia”
(AER#
2020345109).
Per PA5
Sections 8.1.,
8.3.7, 8.13., this
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843179
Page 105 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
event should
trigger a
COVID Illness
Visit regardless
of the potential
diagnosis and a
Nasal Swab
needs to be
collected ASAP.
Aug-10-2020
13:12:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843180
Page 106 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-10-2020
13:12:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/10/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843181
Page 107 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-19-2020
20:39:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Close
dPneumonia is entered.
Sep-07-2020
05:52:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edSAE
RECON:AER#2020345109
PNEUMONIA (onset
date:03Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-10-2020
13:11:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11621059Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020
13:11:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment
Entry
3. Sex:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843182
Page 108 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-10-2020
13:12:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-10-2020
13:12:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-10-2020
13:12:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICA
N AMERICANInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843183
Page 109 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
03:48:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Saumitra Dubey Query 1: Closed Data is updated at
V2.
Sep-10-2020
03:00:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened LIMS Query: As
per Lab, Nasal
Swab sample
with Sample ID -
BP8CS0 is
received for
V2_VAX2_L
visit, however
“ELECTRONIC
SAMPLE
TRACKING -
NASAL SWAB”
page is not
updated at
V2_VAX2_L
visit. Please
check and update
the page, else
clarify.
Aug-10-2020
13:12:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843184
Page 110 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-10-2020
13:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020
13:13:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020
13:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843185
Page 111 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-10-2020
13:14:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Diabetes T
ype II
Start Date: UNK/UN
K/1999
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020
13:14:26
(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
Sep-22-2020
15:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response
satisfies query
Sep-22-2020
13:48:31
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Answered Coordinators
informed to
update medical
hx to include
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843186
Page 112 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) pneumonia
Sep-22-2020
12:02:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Reissued:O
penedThanks for the
response.
Smoking is
clinically
significant for
subjects with
pneumonia, but
is missing on
CRF Med Hx.
Please update if
considered
appropriate.
Sep-22-2020
10:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered data correct as
entered
Sep-14-2020
16:23:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened Med Hx on
SDB record
history of
smoking
relevant to
current AE.
Please,
update/revise
accordingly.
Aug-10-2020
13:14:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Diabetes Type IIInitial Entry
1.a Start Date:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843187
Page 113 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-10-2020
13:14:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020
13:14:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-10-2020
13:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Hypertens
ion
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843188
Page 114 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-10-2020
13:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020
13:15:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-10-2020
13:15:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-10-2020
13:15:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843189
Page 115 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c
Date Location User Value Reason
Aug-10-2020
13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Hyperlipi
demia
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843190
Page 116 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Aug-10-2020
13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020
13:15:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-10-2020
13:15:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-10-2020
13:15:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843191
Page 117 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d
Date Location User Value Reason
Aug-12-2020
17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Nearsight
ed
Start Date: UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843192
Page 118 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020
17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020
17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NearsightedInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-12-2020
17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020
17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843193
Page 119 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-22-2020
13:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:smoking
Start Date: Aug/10/
2020
Ongoing: YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843194
Page 120 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Sep-22-2020
13:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020
13:48:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
smokingInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-22-2020
16:42:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Closed Response
satisfies query
Sep-22-2020
13:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Sep-22-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is
after or equal to
the first
vaccination date
10/Aug/2020.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843195
Page 121 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Please review
and update as
appropriate.
Sep-22-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-22-2020
13:48:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Pneumoni
a
Start Date: Sep/3/202
0
Ongoing: NO
End Dat
e:
Sep/12
/2020Changed
Information
(DELETED)
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843196
Page 122 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-22-2020
13:57:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Pneumoni
a
Start Date: Sep/3/202
0
Ongoing: NO
End Dat
e:
Sep/12
/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843197
Page 123 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
6Changed
Information
(DELETED)
Sep-22-2020
13:57:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
PneumoniaChanged
Information
(DELETED)
Sep-22-2020
13:57:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
PneumoniaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-22-2020
14:57:35
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Erica Weaver Query 2: Closed Response
satisfies query
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843198
Page 124 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
Sep-22-2020
14:57:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Closed Response
satisfies query
Sep-22-2020
14:30:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered specifics of start
date unknown;
site unable to
confirm with
subject at
moment
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Changed
Information
(DELETED)
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Start Date is
after or equal to
the first
vaccination date
10/Aug/2020.
Please review
and update as
appropriate.
Sep-22-2020
13:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-22-2020
13:57:04
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is
after or equal to
the first
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843199
Page 125 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)vaccination date
10/Aug/2020.
Please review
and update as
appropriate.
Sep-22-2020
13:57:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-22-2020
14:26:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/12/2020Changed
Information
(DELETED)
Sep-22-2020
13:57:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/12/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843200
Page 126 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
171.0Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843201
Page 127 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
5. Unit:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.6Initial Entry
7.a
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
7.a Record Identifier:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843202
Page 128 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-10-2020
13:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843203
Page 129 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020
09:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020
09:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
224774Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843204
Page 130 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
13:16:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
13:16:41
(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
12:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-11-2020
08:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM QUERY:
'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
confirm if
sample was
collected and
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843205
Page 131 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
consider
updating
associated
barcode at
sample ID as
appropriate.
Thank you.
Aug-10-2020
13:16:41
(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-10-2020
13:16:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
12:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPLNT
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
12:13:25ACV0PFEINFP6000 Data Entry:
BPLNTDInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843206
Page 132 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
5.b
Date Location User Value Reason
Aug-11-2020
12:13:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPLNT
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020
12:13:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLNTFInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020
12:13:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3CL
NInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843207
Page 133 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Aug-11-2020
12:13:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3CLNInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020
12:14:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3CLPInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-11-2020
12:14:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3CLPInitial Entry
5.e
Date Location User Value Reason
Aug-11-2020
12:14:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3CL
RInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843208
Page 134 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.e Sample ID
Date Location User Value Reason
Aug-11-2020
12:14:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3CLRInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843209
Page 135 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
13:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
13:16:48
(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
12:14:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-11-2020
08:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM QUERY:
'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
confirm if
sample was
collected and
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843210
Page 136 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
consider
updating
associated
barcode at
sample ID as
appropriate.
Thank you.
Aug-10-2020
13:16:48
(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-10-2020
13:16:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
12:14:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3CL
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
12:14:35ACV0PFEINFP6000 Data Entry:
BP3CLMInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843211
Page 137 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843212
Page 138 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020
09:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020
09:56:48
(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
09:56:48
(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
09:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020 11:20Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843213
Page 139 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020
09:56:48
(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
09:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020
09:56:48
(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
09:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PER
IODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843214
Page 140 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-11-2020
09:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843215
Page 141 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-10-2020
13:18:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843216
Page 142 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
15:01:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843217
Page 143 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
E
R
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843218
Page 144 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-22-2020
12:18:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:FATIGU
E
Were fever
or systemi
c symptom
s present o
n the last
day the Su
bject Diar
y was com
pleted?:YES
Ongoin
g?
NO
Sto
p D
ate:
A
ug
/1
8/
20
20Transcription
Error
Sep-22-2020
10:59:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:FATIGU
ETranscription
Error
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843219
Page 145 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever
or systemi
c symptom
s present o
n the last
day the Su
bject Diar
y was com
pleted?:YES
Ongoin
g?
NO
Sto
p D
ate:
A
ug
/3
1/
20
20
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843220
Page 146 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.b Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-22-2020
13:02:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Closed Response
satisfies query
Sep-22-2020
12:18:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/18/2020Transcription
Error
Sep-22-2020
10:59:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-22-2020
10:59:33
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?Transcription
Error
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843221
Page 147 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada) NO
Stop Date:
Aug/31/2020
Sep-11-2020
06:05:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Sagaya Mythili Query 1: Opened e-Diary: Per
eDiary records,
FATIGUE is
reported on Last
day however
the last day in
Inform is
entered as 'No'
for the same.
Please verify
and update.
Else, clarify.
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843222
Page 148 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NO
2.c Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LL
SInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843223
Page 149 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TIN
GInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843224
Page 150 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NO
2.e Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843225
Page 151 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NO
2.f Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED M
USCLE
PAINInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843226
Page 152 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NO
2.g Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINTInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843227
Page 153 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
PAIN
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NO
2.h Symptom:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED J
OINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843228
Page 154 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4. Injection Site Body Side:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reac
tion::RE
DN
ES
S
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843229
Page 155 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Rea
ction::SW
EL
LIN
G
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843230
Page 156 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-10-2020
15:03:12
(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-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::PAIN
AT IN
JECT
ION
SITE
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843231
Page 157 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SI
TEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020
15:03:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843232
Page 158 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.6
Temperature
Unit:C
Temperature
Location::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843233
Page 159 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
15:03:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843234
Page 160 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
15:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
15:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
15:06:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
15:03:58
(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.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843235
Page 161 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
15:03:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
15:06:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8CS0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
15:06:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP8CS0Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843236
Page 162 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 11:57Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843237
Page 163 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
15:09:58
(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
Sep-10-2020
15:09:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PER
IODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843238
Page 164 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-10-2020
15:09:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843239
Page 165 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
09:17:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-13-2020
10:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Changed data
per query
Oct-12-2020
12:24:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 2: Opened Please enter
sample
tracking form
and EOT
form.
Oct-12-2020
12:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Closed Response
satisfies query
Oct-12-2020
12:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Opened Please enter
sample
tracking form
Oct-09-2020
16:40:49
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843240
Page 166 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843241
Page 167 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843242
Page 168 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGU
E
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:YES
Ongoi
ng?
NO
Sto
p D
ate:
Se
p/
12
/2
02
0Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843243
Page 169 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.b Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/12/2020Initial Entry
2.c
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843244
Page 170 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843245
Page 171 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.d Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843246
Page 172 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.e Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843247
Page 173 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843248
Page 174 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED JInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843249
Page 175 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843250
Page 176 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843251
Page 177 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843252
Page 178 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITE
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843253
Page 179 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-09-2020
16:43:15
(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
Oct-09-2020
16:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843254
Page 180 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
10:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
10:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
10:41:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
10:40:51
(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.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843255
Page 181 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-13-2020
10:40:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
10:41:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFV0HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
10:41:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLFV0HInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020
10:41:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8S9MInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843256
Page 182 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Sample ID
Date Location User Value Reason
Oct-13-2020
10:41:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BR8S9MInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020
10:41:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFV0JInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020
10:41:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLFV0JInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843257
Page 183 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
13:55:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/6/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843258
Page 184 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Assessments
Date Location User Value Reason
Oct-06-2020
13:57:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
13:55:53
(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.
Oct-06-2020
13:55:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843259
Page 185 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-06-2020
13:57:17
(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
Oct-06-2020
13:57:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
If No, why?
Subject visited the hos
pital for unrelated illn
ess. see SAE report fo
r symptomsInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843260
Page 186 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-13-2020
10:41:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
10:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020
13:37:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-29-2020
08:52:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-19-2020
11:46:37ACV0PFEINFP6000 Katherine
PuigQuery 1: Opened IVRS
Reconciliation:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843261
Page 187 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)BLIND
BROKEN? in
IMPALA is YES
but
TREATMENT
UNBLINDED
form has not
been completed
in InForm. Please
review and
update as
appropriate. Else,
clarify. Thank
you.
Oct-13-2020
10:41:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843262
Page 188 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843263
Page 189 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020
16:34:15
(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
Sep-22-2020
13:32:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 2: Closed Response
satisfies query
Sep-22-2020
13:25:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Closed Response
satisfies query
Sep-22-2020
11:01:07
(UTC-05:00)ACV0PFEINFP6000 Query 2: Answered subject has not
had a COVID
Illness visit yet
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843264
Page 190 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
Sep-22-2020
11:00:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Site will submit
updated SAE
report when
information is
available
Sep-21-2020
13:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 2: Opened Clin: Please the
COVID-19
related event
PNEUMONIAE
(the related
symptoms and all
the relevant
information’s)
should be also
documented on
the COVID
Illness CRF
forms.
Sep-14-2020
17:28:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Opened Clinical_SAE
narrative "Hg 6.0
g/dl with scope
revealing no
active bleeding in
lungs.” Please
submit fu SAE to
clarify course
including whether
this a
bronchoscope?
Did subject
present with
hemoptysis?
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843265
Page 191 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
pneumoniaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-16-2020
15:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/13/2020 UN
K:UNKTranscription
Error
Sep-16-2020
13:59:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/12/2020 UN
K:UNKNew
Information
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (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-2021-5683-0843266
Page 192 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Sep-14-2020
16:34:15
(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
Sep-17-2020
19:28:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Closed Clinical_as per
the fu SAE form,
subject was
discharged on 13
Sep. Awaiting
clinical course
details to be
provided.
Sep-17-2020
15:04:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
NO
Did this serious event rTranscription
Error
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843267
Page 193 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically impor
tant serious event
NO
Sep-16-2020
12:04:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Sep-16-2020
12:04:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Subject is still
hospitalized, will
f/u with any
additional
clinical
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843268
Page 194 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
information
upon discharge.
Sep-16-2020
12:04:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
YES
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically impor
tant serious eventSubject is still
hospitalized, will
f/u with any
additional
clinical
information
upon discharge.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843269
Page 195 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
Sep-16-2020
08:04:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE
pneumonia:
Response to "Is
the adverse
event serious?"
is 'No' but
"Serious
Adverse Event
Number" is
present.
Sep-15-2020
12:21:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Opened Clinical_as this
has been
reported to
safety, please
update
seriousness.
Sep-14-2020
16:34:15
(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
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843270
Page 196 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event is
due to:
OTHER
If Other, specify:
unblinded per tx ph
ysician physician re
quest sponsor notif
y of unblindedInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-16-2020
13:59:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESNew
Information
Sep-14-2020
16:34:15ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843271
Page 197 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Sep-17-2020
11:52:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Sep-16-2020
13:59:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Clo
sedClose Auto Query
Sep-16-2020
13:58:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Op
enedFor AE pneumonia: Response to
"What was the outcome of this
adverse event?" is 4 but End
Date/Time is missing.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843272
Page 198 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
13:58:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dNew Information
Sep-16-2020
13:58:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Sep-16-2020
13:58:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RED/
RESO
LVED
WIT
H SE
QUE
LAENew Information
Sep-16-2020
08:09:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020345109 ,outcome
was reported as Recovered/Resolved
with Sequelae to Safety however,
recorded as UNKNOWN on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Sep-14-2020
16:34:15ACV0PFEINFP6000 auto query
(autoquery)Query
1: OpFor AE pneumonia: Response to
"What was the outcome of this
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843273
Page 199 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US &
Canada)enedadverse event?" is 'Unknown' but
End Date/Time is provided or "Is the
adverse event still ongoing?" is
marked "Yes".
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
UNK
NOW
NInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020
16:34:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-16-2020
08:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020345109Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843274
Page 200 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
23:34:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-08-2021
15:50:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered DOV cant be
deleted or
erased after
entry
Mar-05-2021
07:53:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Erroneous Visit
is marked, but
date of visit is
entered. Please
either untick
the erroneous
visit button if
visit occurred,
or mark any
forms
containing data
within this visit
as Not
Done/Not
Applicable at
the form level.
Mar-03-2021
12:17:28
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit
is marked, but
date of visit is
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843275
Page 201 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)entered. Please
either untick
the erroneous
visit button if
visit occurred,
or mark any
forms
containing data
within this visit
as Not
Done/Not
Applicable at
the form level.
Feb-26-2021
07:33:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-03-2021
12:17:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843276
Page 202 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-03-2021
12:17:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Mar-03-2021
12:16:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Feb-26-2021
07:33:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:
eligible per local/nati
onal recommendatio
ns and confirmed to
have received only pl
acebo at Vaccination
1/2Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843277
Page 203 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Nov-04-2020
05:46:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Nov-03-2020
17:52:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-03-2020
17:52:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Changed
Information
Nov-02-2020
08:09:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Katherine Puig Query 1: Opened IVRS
Reconciliation:
Date of BLIND
BROKEN in
IMPALA is
(04-SEP_2020)
but DATE
TREATMENT
UNBLINDED in
InForm is
(06-SEP-2020).
Please review
and update as
appropriate.
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843278
Page 204 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Else, clarify.
Thank you.
Oct-29-2020
08:51:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/6/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Oct-29-2020
08:51:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT SAFETY CO
NCERNInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843279
Page 205 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Oct-29-2020
08:51:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843280
Page 206 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Oct-29-2020
08:51:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843281
Page 207 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021
23:31:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-09-2021
12:22:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Mar-08-2021
23:37:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:O
penedDM : Forms
unfrozen. Please
review and
update. Else,
clarify.
Mar-08-2021
15:48:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Please unfreeze
pages for update
Mar-04-2021
15:07:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:O
penedDM: Please mark
any forms
containing data
within this visit
as Not Done/Not
Applicable at the
form level.
Mar-04-2021
10:24:29ACV0PFEINFP6000 Query 2: Answered Dates cant be
removed, deleted
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (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-2021-5683-0843282
Page 208 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)or erased after
entering.
Mar-03-2021
15:21:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Erroneous Visit is
marked, but date
of visit is entered.
Please either
untick the
erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit
as Not Done/Not
Applicable at the
form level.
Mar-03-2021
15:21:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-03-2021
12:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Visit is erroneous
Mar-03-2021
12:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date
of visit is entered.
Please either
untick the
erroneous visit
button if visit
occurred, or mark
any forms
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843283
Page 209 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
containing data
within this visit
as Not Done/Not
Applicable at the
form level.
Mar-01-2021
12:17:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete
‘Vaccination,
Immunogenicity
and Nasal Swab
forms' at this
visit. Thank you.
Feb-26-2021
07:34:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-03-2021
12:04:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843284
Page 210 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-09-2021
12:21:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Mar-09-2021
12:21:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Feb-26-2021
07:34:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Feb/16/2021Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843285
Page 211 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-09-2021
12:21:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Mar-09-2021
12:21:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Feb-26-2021
07:36:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-09-2021
12:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-09-2021
12:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843286
Page 212 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-26-2021
07:36:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-09-2021
12:21:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Mar-09-2021
12:20:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Feb-26-2021
07:36:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-09-2021
12:21:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843287
Page 213 of 214
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020
10:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-11-2020
09:56:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Aug-10-2020
13:13:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-13-2020
10:41:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Aug-11-2020
09:56:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/10/2020Initial Entry
Aug-10-2020
13:13:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/10/2020Initial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843288
Page 214 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-18-2020
17:45:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f8d\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843289