Document text
Page 1 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920024
Page 2 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920025
Page 3 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10901140]
2.Birth Date: /1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920026
Page 4 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920027
Page 5 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920028
Page 6 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920029
Page 7 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Latex Allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Dust]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Tomatoes]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920030
Page 8 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1980
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthmatic Bronchitis]
Start Date: UNK/UNK/1985
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kidney Stones]
Start Date: UNK/UNK/1996
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Endometriosis]
Start Date: UNK/UNK/2003
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[polycystic ovarian syndrome]
Start Date: UNK/UNK/2003
Ongoing: YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920031
Page 9 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II Diabetes]
Start Date: Jun/UNK/2020
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eczema]
Start Date: UNK/UNK/1985
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Meniscus Repair Surgery due to meniscus tear]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACL surgery]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920032
Page 10 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[torn ACL]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920033
Page 11 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [124.0]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [45.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920034
Page 12 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920035
Page 13 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [46471]
3.Randomization Group: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920036
Page 14 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3GCY]
5.bSample ID [BP3GCX]
5.cSample ID [BP3GCW]
5.dSample ID [BPLG1R]
5.eSample ID [BPLG1S]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920037
Page 15 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3GCN]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920038
Page 16 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/11/2020 16:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920039
Page 17 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920040
Page 18 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920041
Page 19 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920042
Page 20 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920043
Page 21 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920044
Page 22 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920045
Page 23 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BN67X3]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920046
Page 24 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/31/2020 16:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920047
Page 25 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920048
Page 26 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920049
Page 27 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920050
Page 28 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BP8FX5]
5.bSample ID [BLB88J]
5.cSample ID [BLB88K]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920051
Page 29 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920052
Page 30 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920053
Page 31 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920054
Page 32 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920055
Page 33 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920056
Page 34 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920057
Page 35 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920058
Page 36 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920059
Page 37 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920060
Page 38 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920061
Page 39 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920062
Page 40 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920063
Page 41 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920064
Page 42 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920065
Page 43 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 acute appendicitis with
perforation Feb/4/2021 UN
K:UNK NO
End Date Time:
Feb/11/2021 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 localized peritonitis Feb/4/2021 UN
K:UNK NO
End Date Time:
Feb/11/2021 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 pelvic abscess Feb/4/2021 UN
K:UNK NO
End Date Time:
Feb/11/2021 UNK:UN
K
Repeating
Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920066
Page 44 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[acute appendicitis with perforation]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920067
Page 45 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021162151]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920068
Page 46 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[localized peritonitis]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920069
Page 47 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
[appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021162151]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920070
Page 48 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pelvic abscess]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920071
Page 49 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
[appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021162151]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920072
Page 50 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryMedication E
rrorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920073
Page 51 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920074
Page 52 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920075
Page 53 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920076
Page 54 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920077
Page 55 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920078
Page 56 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920079
Page 57 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920080
Page 58 of 224
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920081
Page 59 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920082
Page 60 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920083
Page 61 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920084
Page 62 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920085
Page 63 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920086
Page 64 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920087
Page 65 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920088
Page 66 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920089
Page 67 of 224
***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, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920090
Page 68 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920091
Page 69 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920092
Page 70 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920093
Page 71 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920094
Page 72 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/27/2021
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920095
Page 73 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920096
Page 74 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920097
Page 75 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/27/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920098
Page 76 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BMN9F6]
5.bSample ID [BMN9F5]
5.cSample ID [BP8G46]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920099
Page 77 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BP8G3L]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920100
Page 78 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/27/2021 13:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920101
Page 79 of 224
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920102
Page 80 of 224
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/18/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920103
Page 81 of 224
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BV0F6P]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920104
Page 82 of 224
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 14:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920105
Page 83 of 224
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920106
Page 84 of 224
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920107
Page 85 of 224
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920108
Page 86 of 224
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920109
Page 87 of 224
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920110
Page 88 of 224
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920111
Page 89 of 224
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920112
Page 90 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920113
Page 91 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920114
Page 92 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 08:43:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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.
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920115
FDA-CBER-2021-5683-0920116
Page 94 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-27-2021 14:21:19 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920117
Page 95 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 08:43:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 15:44:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-11-2021 09:04:18 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 08:54:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920118
Page 96 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Matthew Hong Approved Mar-10-2021 16:54:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-10-2021 14:34:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-10-2021 09:01:09 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-10-2021 08:17:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-10-2021 07:55:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920119
Page 97 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, LisaCohen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-09-2021 13:08:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-19-2021 15:38:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-19-2021 13:42:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-19-2021 09:24:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920120
Page 98 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-19-2021 03:23:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-18-2021 17:18:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-18-2021 16:22:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-18-2021 14:00:50 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920121
Page 99 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-18-2021 13:15:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-01-2021 12:05:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-01-2021 10:03:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Jan-29-2021 12:27:48 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920122
Page 100 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, 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 Jan-29-2021 12:06:55 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Jan-27-2021 14:35:47 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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 Jan-27-2021 14:20:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Wayne Harper Approved Oct-08-2020 15:45:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920123
Page 101 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, WayneHarper, 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-02-2020 16:47:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Wayne Harper Approved Sep-11-2020 13:47:06 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WayneHarper, 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.
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920124
Page 102 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 14:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020 14:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920125
Page 103 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 14:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/11/2020Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920126
Page 104 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 14:54:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10901140Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 14:53:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1976Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 14:54:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 14:54:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020 14:54:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920127
FDA-CBER-2021-5683-0920128
Page 106 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 14:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 14:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 14:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920129
Page 107 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 14:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Latex Allerg
y
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Latex AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 14:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020 14:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920130
Page 108 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b
Date Location User Value Reason
Aug-12-2020 14:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Allergy to D
ust
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:57:39
(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-12-2020 14:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to DustInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 14:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 14:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920131
Page 109 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-12-2020 14:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Allergy to To
matoes
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:58:11
(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-12-2020 14:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to TomatoesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-12-2020 14:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-12-2020 14:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920132
Page 110 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-12-2020 15:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Allergic Rhin
itis
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:02:02
(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 15:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic RhinitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-12-2020 15:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020 15:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-12-2020 15:02:37 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920133
Page 111 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Numbe
r:5
Medical History
Term:Asthma
Start Date: UNK/UNK/1
980
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:02:37
(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
Aug-12-2020 15:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-12-2020 15:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-12-2020 15:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-12-2020 15:03:06
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 6Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920134
Page 112 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) er:
Medical History
Term:Asthmatic Bro
nchitis
Start Date: UNK/UNK/19
85
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:03:06
(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
Aug-12-2020 15:03:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Asthmatic BronchitisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-12-2020 15:03:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-12-2020 15:03:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-12-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920135
Page 113 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History
Term:Kidney Ston
es
Start Date: UNK/UNK/1
996
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Kidney StonesInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-12-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-12-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-12-2020 15:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920136
Page 114 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History
Term:Endometriosi
s
Start Date: UNK/UNK/2
003
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EndometriosisInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-12-2020 15:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-12-2020 15:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-15-2020 12:36:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:9this is the medical
term
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920137
Page 115 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical Histo
ry Term:polycystic ovaria
n syndrome
Start Date: UNK/UNK/2003
Ongoing: YES
Aug-12-2020 15:05:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Polycystic Ovari
an Syndrome
Start Date: UNK/UNK/2003
Ongoing: YESInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920138
Page 116 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.i Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:05:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-15-2020
13:32:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2:
ClosedDiscrepancy has
been closed.
Aug-15-2020
12:36:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answeredthis is the medical
term
Aug-15-2020
12:36:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
polycystic
ovarian sy
ndromethis is the medical
term
Aug-14-2020
07:25:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1:
DeletedClosed by DM:
PM_Related query
has been issued
Aug-13-2020
00:28:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2:
OpenedSpacing: Verbatim
Term contains
leading, trailing or
more than one
consecutive space.
Aug-12-2020
15:05:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
CandidateExtra blank spaces
are present
between words in
the
Disease/Syndrome
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920139
Page 117 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Term which may
impact coding.
Please review and
remove any extra
spaces.
Aug-12-2020
15:05:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Polycystic
Ovarian S
yndromeInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920140
FDA-CBER-2021-5683-0920141
Page 119 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.j Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 08:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Closed Response satisfies
query
Aug-15-2020 12:34:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered stable disease
Aug-14-2020 08:50:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Opened Per IC #3, medical
history condition
must be stable at
least 6 weeks before
enrollment. Please
confirm if any
significant change
in therapy or
hospitalization for
worsening disease
occured during the
6 weeks prior to
enrollment.
Aug-12-2020 15:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type II DiabetesInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-12-2020 15:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.j Ongoing:
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0920142
Page 120 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-12-2020 15:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-12-2020 15:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:Eczema
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920143
Page 121 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.k Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EczemaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-12-2020 15:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-12-2020 15:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-12-2020 15:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical H
istory Ter
m:Meniscus Repair Sur
gery due to meniscus
tear
Start Date
:UNK/UNK/2016Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920144
Page 122 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
UNK/UNK/2016
1.l Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Meniscus Repair Surgery due to
meniscus tearInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-12-2020 15:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-12-2020 15:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.m
Date Location User Value Reason
Aug-15-2020 12:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:13New Information
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920145
Page 123 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical Histor
y Term:ACL surgery
Start Date: UNK/UNK/20
03
Ongoing: NO
End Date:
UNK/UNK
/2003
Aug-12-2020 15:10:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:ACL surgery due
to torn ACL
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/20
03Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920146
Page 124 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.m Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:10:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-15-2020
13:33:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Aug-15-2020
12:36:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredNew
Information
Aug-15-2020
12:36:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ACL surgeryNew
Information
Aug-13-2020
04:30:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedMultiple
concepts in
the term ACL
SURGERY
DUE TO
TORN ACL.
Split the term
into ACL
SURGERY
and TORN
ACL and
submit
separately.
Thank you.
Aug-12-2020
15:10:41ACV0PFEINFP6000 Data Entry:
ACL surgeryInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0920147
Page 125 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time
(US & Canada)due to torn A
CL
1.m Start Date:
Date Location User Value Reason
Aug-12-2020 15:10:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-12-2020 15:10:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.n
Date Location User Value Reason
Aug-15-2020 12:37:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical History
Term:torn ACL
Start Date: UNK/UNK/20
03
Ongoing: NO
End Date:
UNK/UNK/
2003Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920148
Page 126 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.n Line/MH Number:
Date Location User Value Reason
Aug-15-2020 12:37:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-15-2020 12:37:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
torn ACLInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-15-2020 12:37:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-15-2020 12:37:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920149
Page 127 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
124.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920150
Page 128 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
45.5Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.4
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 15:17:23 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920151
Page 129 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)ORAL CAVITY
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920152
Page 130 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920153
Page 131 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-12-2020 15:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920154
Page 132 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 15:18:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 15:18:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
46471Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920155
Page 133 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 15:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 15:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 08:33:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-13-2020 01:21:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-12-2020 15:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-12-2020 15:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-12-2020 15:19:02
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESTranscription Error
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920156
FDA-CBER-2021-5683-0920157
Page 135 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 08:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3GCXInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020 08:34:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3GCWInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 08:34:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3GCWInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020 08:34:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLG1RInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 08:34:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLG1RInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020 08:34:57
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BPLG1SInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920158
Page 136 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 08:34:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLG1SInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920159
FDA-CBER-2021-5683-0920160
Page 138 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug/11/2020
5.a
Date Location User Value Reason
Aug-13-2020 08:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3GCNInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 08:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3GCNInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920161
Page 139 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 15:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 15:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 15:20:07
(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-12-2020 15:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020 16:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 15:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920162
FDA-CBER-2021-5683-0920163
Page 141 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 15:20:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920164
Page 142 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 08:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920165
Page 143 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Symptom:: FAInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920166
Page 144 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920167
Page 145 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920168
Page 146 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.e
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920169
Page 147 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE
PAIN
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920170
Page 148 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE 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-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920171
Page 149 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T 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-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:RE
DN
ES
S
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920172
Page 150 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920173
Page 151 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c
Date Location User Value Reason
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 08:35:15
(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
Sep-01-2020 08:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920174
Page 152 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.3
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920175
Page 153 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 08:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920176
Page 154 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920177
Page 155 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920178
Page 156 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 16:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 16:40:31
(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-31-2020 16:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 16:40:31
(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-31-2020 16:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 16:40:39
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920179
Page 157 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) Sample ID: BN67X3
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 16:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN67X3Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920180
Page 158 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 08:36:11
(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-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 16:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920181
Page 159 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 08:36:11
(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-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 08:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920182
Page 160 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 08:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920183
Page 161 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Symptom:: FAInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920184
Page 162 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920185
Page 163 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920186
Page 164 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.e
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920187
Page 165 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.f Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920188
Page 166 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.g Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E 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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920189
Page 167 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
3. Injection Site Location:
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920190
Page 168 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.b
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920191
Page 169 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:48:48
(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-05-2020 08:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920192
Page 170 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 16:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 16:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 16:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 16:47:47
(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.
Oct-02-2020 16:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 16:47:56
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920193
Page 171 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) Sample ID: BP8FX5
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 16:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8FX5Initial Entry
5.b
Date Location User Value Reason
Oct-02-2020 16:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB88JInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 16:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB88JInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 16:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB88KInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 16:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB88KInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920194
Page 172 of 224
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-05-2020 08:49:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-05-2020 08:49:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020 08:49:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920195
Page 173 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920196
Page 174 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920197
Page 175 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920198
Page 176 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 13:15:53
(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
Mar-12-2021
13:33:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 6:
ClosedResponse satisfies
query
Mar-12-2021
07:47:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 6:
Answeredfaxed already.
Subject does not
take DM
medication
Mar-11-2021
12:48:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 6:
OpenedClinical - please
submit a SAE
update with the
subject's med Hx
(including T2DM)
and any
concomitant
medications
subject was
receiving for
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920199
Page 177 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
T2DM
Mar-11-2021
12:47:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 5:
Closedrewording
Mar-11-2021
12:45:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 5:
OpenedClinical - please
submit a SAE
update with the
subject's med Hx
(including T2DM)
and all concomitant
medications
subject was
receiving when
SAE began
Mar-10-2021
14:37:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
ClosedResponse satisfies
query
Mar-10-2021
09:03:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 3:
ClosedDiscrepancy has
been closed.
Mar-10-2021
08:17:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
Answeredper query
Mar-10-2021
08:17:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
Answeredper query
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920200
Page 178 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-10-2021
08:17:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
acute appe
ndicitis wi
th perforat
ionper query
Mar-10-2021
04:05:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
OpenedSAE RECON:
AER#2021162151,
event term was
recorded as 'acute
appendicitis with
perforation and
localized
peritonitis with
pelvic abscess'for
coding and
reconciliation.
Please consider to
split the terms as 3
separate entries to
match Safety
database.
Mar-09-2021
22:17:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse satisfies
query
Mar-09-2021
14:37:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 3:
OpenedMultiple concepts
in the term
ACUTE
APPENDICITIS
WITH
PERFORATION
AND
LOCALIZED
PERITONITIS
WITH PELVIC
ABSCESS. Split
the term into
ACUTE
APPENDICITIS
WITH
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920201
Page 179 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
PERFORATION
and LOCALIZED
PERITONITIS and
PELVIC
ABSCESS and
report as 3 separate
entries. Thank you.
Mar-09-2021
13:08:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredNew Information
Mar-09-2021
13:08:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
acute appe
ndicitis wi
th perforat
ion and lo
calized per
itonitis wit
h pelvic ab
scessNew Information
Mar-09-2021
09:34:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedClinical - event
term is 'ruptured
appendix';
however, SAE
report event term
updated to 'Acute
appendicitis with
perforation and
located peritonitis,
with pelvic
abscess'. Please
harmonize event
reporting, and
update where
appropriate
Mar-05-2021
21:25:58
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 1:
ClosedQuery closed; will
follow for
requested surgery
date information.
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920202
Page 180 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US &
Canada)
Mar-03-2021
17:37:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answeredsurgery was on 08
Feb 2021, we will
send in f/u report
Feb-22-2021
09:32:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedClinical - please
update SAE report
with the specific
date that
emergency surgery
was performed
Feb-18-2021
13:15:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
ruptured a
ppendixInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 13:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021 UNK:UNKNew Information
Mar-09-2021 09:32:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed onset date of
08Feb21 in both
locations now
Mar-09-2021 05:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021162151
,onset date was
recorded as
04Feb2021 in Safety
database however,
recorded as
08Feb2021 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920203
Page 181 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
required, please
submit a follow-up
SAE form.
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/11/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial 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
Mar-05-2021 21:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for requested
COVID test
information.
Mar-03-2021 17:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered we will include that
in f/u report
Mar-01-2021 10:55:17
(UTC-05:00) EasternACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - thank
you; please include
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920204
Page 182 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) the COVID test
date in the report
Feb-25-2021 17:51:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered it was negative per
pt, but we are
awaiting medical
records to confirm
Feb-22-2021 09:33:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2021162151] to
document if
COVID testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Feb-19-2021 03:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE ruptured
appendix: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920205
Page 183 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life thre
atening?
YES
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920206
Page 184 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 22:18:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-09-2021 13:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Mar-09-2021 13:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Mar-09-2021 09:33:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Con Med for
event is NO; however
SAE update states
subject received
amoxicillin/clavulanate
antibiotic. Please
review Con med for
event, and update as
applicable
Mar-01-2021 10:57:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for requested
antibiotic usage
information.
Feb-25-2021 17:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered awaiting medical
records for specific
antibiotics
Feb-22-2021 09:30:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Con Med for
SAE is 'NO'; however,
SAE report states
subject received
antibiotics. Please
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920207
Page 185 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review, harmonize
reporting, and update
where applicable
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 13:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920208
Page 186 of 224
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-19-2021 03:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021162151Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920209
Page 187 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021
17:10:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Mar-10-2021
14:34:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Mar-10-2021
14:34:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
localized peri
tonitisTranscription
Error
Mar-10-2021
09:11:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedSpacing:
Verbatim Term
contains
leading,
trailing or
more than one
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0920210
Page 188 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
consecutive
space.
Mar-10-2021
08:20:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
localized peri
tonitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 10:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-11-2021 09:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021 UNK:UNKNew Information
Mar-11-2021 08:54:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-11-2021 08:54:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 UNK:UNKTranscription Error
Mar-10-2021 14:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021162151
onset date was
recorded as
04Feb2021 in Safety
database however,
recorded as
10Feb2021 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Mar-10-2021 08:22:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021 UNK:UNKTranscription Error
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920211
Page 189 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/10/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 08:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/11/2021 UNK:UNKNew Information
Mar-10-2021 08:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKTranscription Error
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Mar/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial 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
Mar-10-2021 14:36:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920212
Page 190 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE localized
peritonitis :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
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.
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920213
Page 191 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021 13:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-11-2021 15:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered per query
Mar-11-2021 15:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
appendicitisper query
Mar-11-2021 12:37:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - other
case for event is
UNKNOWN;
however, the event
occurs in the
setting of
appendicitis. Please
review for potential
other cause, and
update if
appropriate
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHERInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0920214
Page 192 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
If Other, specify:
unk
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed answered
Mar-11-2021 09:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-11-2021 09:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Mar-11-2021 06:07:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Was a
Non-Drug
Treatment given?"
is missing. Kindly
review and update.
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0920215
Page 193 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-10-2021 08:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-10-2021 08:20:25
(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
Mar-10-2021 14:36:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021162151Initial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920216
Page 194 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pelvic abscessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 10:44:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-11-2021 09:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-11-2021 09:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021 UNK:UNKTranscription Error
Mar-10-2021 14:40:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021162151
onset date was
recorded as
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0920217
Page 195 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
04Feb2021 in Safety
database however,
recorded as
10Feb2021 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 09:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/11/2021 UNK:UNKto match safety
dates
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial 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).
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920218
Page 196 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Mar-10-2021 14:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE pelvic
abscess: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 08:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important serio
us eventInitial Entry
090177e196ae3d7b\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920219
Page 197 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EV
…[truncated]