Document text
Page 1 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897580
Page 2 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/24/2020
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897581
Page 3 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191229]
2.Birth Date: /1957
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897582
Page 4 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897583
Page 5 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897584
Page 6 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897585
Page 7 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1988
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Septal deviation - nasal]
Start Date: Aug/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2013
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent abdominal pain]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897586
Page 8 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic constipation]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2015
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/1998
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cyst - bilateral breasts]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897587
Page 9 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral carpal tunnel syndrome]
Start Date: UNK/UNK/2006
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis - knees]
Start Date: UNK/UNK/1995
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: UNK/UNK/2013
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent lumbar pain]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897588
Page 10 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2001
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1995
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cystectomy - bilateral breasts]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897589
Page 11 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897590
Page 12 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
2.Weight: [117.7]
3.Unit: LB
4.Height: [62.5]
5.Unit: in
6.Body Mass Index: [21.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: EAR
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897591
Page 13 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897592
Page 14 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/24/2020
2.Randomization Number: [264155]
3.Randomization Group: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897593
Page 15 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BP98GT]
5.bSample ID [BPRWV5]
5.cSample ID [BPRWV6]
5.dSample ID [BPRWV7]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897594
Page 16 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BP98N1]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897595
Page 17 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 13:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897596
Page 18 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897597
Page 19 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897598
Page 20 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: EAR
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897599
Page 21 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897600
Page 22 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BP98T2]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897601
Page 23 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 11:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897602
Page 24 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897603
Page 25 of 316
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897604
Page 26 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897605
Page 27 of 316
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897606
Page 28 of 316
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897607
Page 29 of 316
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897608
Page 30 of 316
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897609
Page 31 of 316
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897610
Page 32 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897611
Page 33 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897612
Page 34 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897613
Page 35 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897614
Page 36 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897615
Page 37 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897616
Page 38 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897617
Page 39 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897618
Page 40 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897619
Page 41 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897620
Page 42 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897621
Page 43 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897622
Page 44 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
1. DELETED ADVERS
E EVEN
T 1 Motor Vehicle Collision Nov/4/2020
UNK:UNK NO
End Date Time:
Nov/4/2020 U
NK:UNK
Repeating
Pages
2. ADVERS
E EVEN
T 2 Small Parafalcine Subdu
ral hematoma Nov/4/2020
UNK:UNK NO
End Date Time:
Dec/3/2020 U
NK:UNK
Repeating
Pages
3. ADVERS
E EVEN
T 3 Severe T2 Distraction In
jury Nov/4/2020
UNK:UNK YES Repeating
Pages
4. ADVERS
E EVEN
T 4 Right Hemopneumothor
ax Nov/4/2020
UNK:UNK NO
End Date Time:
Dec/4/2020 U
NK:UNK
Repeating
Pages
5. ADVERS
E EVEN
T 5 Left Pneumothorax Nov/4/2020
UNK:UNK NO
End Date Time:
Dec/4/2020 U
NK:UNK
Repeating
Pages
6. ADVERS
E EVEN
T 6 Bilateral Rib Fractures Nov/4/2020
UNK:UNK YES Repeating
Pages
7. ADVERS
E EVEN
T 7 Left Pulmonary Emboli Nov/4/2020
UNK:UNK NO
End Date Time:Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897623
Page 45 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
Dec/4/2020 U
NK:UNK
8. ADVERS
E EVEN
T 8 Left Superficial Femoral
Vein Deep Vein Thromb
osis Nov/4/2020
UNK:UNK NO
End Date Time:
Dec/4/2020 U
NK:UNK
Repeating
Pages
9. ADVERS
E EVEN
T 9 Sigmoid Volvulus Nov/4/2020
UNK:UNK NO
End Date Time:
Nov/5/2020 U
NK:UNK
Repeating
Pages
10. ADVERS
E EVEN
T 10 Injury Secondary to Ped
estrian-Car Accident Nov/4/2020
UNK:UNK YES Repeating
Pages
11. ADVERS
E EVEN
T 11 Spinal Cord Compressio
n Nov/4/2020
UNK:UNK YES Repeating
Pages
12. ADVERS
E EVEN
T 12 Hyperemic Bowel Nov/4/2020
UNK:UNK NO
End Date Time:
Nov/5/2020 U
NK:UNK
Repeating
Pages
13. ADVERS
E EVEN
T 13 Cardiac Arrest Nov/21/202
0 UNK:UN
K NO
End Date Time:
Nov/21/2020 U
NK:UNK
Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897624
Page 46 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
14. ADVERS
E EVEN
T 14 Cardiac Arrest Nov/23/202
0 UNK:UN
K NO
End Date Time:
Nov/23/2020 U
NK:UNK
Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897625
Page 47 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Motor Vehicle Collision ]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/4/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897626
Page 48 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Vehicle Collision ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728 ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897627
Page 49 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Small Parafalcine Subdural hematoma]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/3/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897628
Page 50 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897629
Page 51 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Severe T2 Distraction Injury]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).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?
YES
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897630
Page 52 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897631
Page 53 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Right Hemopneumothorax]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/4/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897632
Page 54 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897633
Page 55 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Left Pneumothorax]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/4/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897634
Page 56 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897635
Page 57 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Bilateral Rib Fractures]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897636
Page 58 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897637
Page 59 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Left Pulmonary Emboli]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/4/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897638
Page 60 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897639
Page 61 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Left Superficial Femoral Vein Deep Vein Thrombosis]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/4/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897640
Page 62 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897641
Page 63 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Sigmoid Volvulus]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/5/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897642
Page 64 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hyperemic Bowel]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897643
Page 65 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Injury Secondary to Pedestrian-Car Accident]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897644
Page 66 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897645
Page 67 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Spinal Cord Compression]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
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?
YES
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897646
Page 68 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[T2 distraction injury]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897647
Page 69 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [12]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Hyperemic Bowel]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/5/2020 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?
NO
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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897648
Page 70 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury Secondary to Pedestrian-Car Accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897649
Page 71 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [13]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Cardiac Arrest]
4.Start Date Time: Nov/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/21/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897650
Page 72 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury secondary to pedestrian-car accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897651
Page 73 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [14]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Cardiac Arrest]
4.Start Date Time: Nov/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/23/2020 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
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897652
Page 74 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Injury secondary to pedestrian-vehicle accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020431728]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897653
Page 75 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897654
Page 76 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897655
Page 77 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897656
Page 78 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[ ]
5.Date: //
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897657
Page 79 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897658
Page 80 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897659
Page 81 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897660
Page 82 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897661
Page 83 of 316
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897662
Page 84 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897663
Page 85 of 316
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897664
Page 86 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897665
Page 87 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897666
Page 88 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897667
Page 89 of 316
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897668
Page 90 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897669
Page 91 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897670
Page 92 of 316
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897671
Page 93 of 316
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897672
Page 94 of 316
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897673
Page 95 of 316
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897674
Page 96 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897675
Page 97 of 316
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897676
Page 98 of 316
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897677
Page 99 of 316
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897678
Page 100 of 316
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897679
Page 101 of 316
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897680
Page 102 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/12/2020
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897681
Page 103 of 316
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897682
Page 104 of 316
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897683
Page 105 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-24-2020 15:29:31 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897684
Page 106 of 316
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Dec-07-2020 09:36:25 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-03-2020 14:07:30 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-26-2020 17:18:11 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 16:09:55 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897685
Page 107 of 316
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897686
Page 108 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-24-2020 15:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-24-2020 15:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897687
Page 109 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-24-2020 15:28:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Sep/24/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897688
Page 110 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-07-2020
08:41:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-06-2020
11:35:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered data entered
Nov-06-2020
05:58:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020431728
motor vehicle
collision(onset
date:05Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-24-2020
15:27:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10191229Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-24-2020 15:27:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897689
Page 111 of 316
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3. Sex:
Date Location User Value Reason
Sep-24-2020 15:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-24-2020 15:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-24-2020 15:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AM
ERICANInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897690
Page 112 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 15:29:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897691
Page 113 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-24-2020 15:29:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 15:29:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 15:29:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897692
Page 114 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-24-2020 15:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Myopia
Start Date: UNK/UNK
/1988
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 15:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-24-2020 15:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.a Ongoing:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897693
Page 115 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 15:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-24-2020 15:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Septal deviati
on - nasal
Start Date: Aug/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897694
Page 116 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 15:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Septal deviation - nasalInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-24-2020 15:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-24-2020 15:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-24-2020 15:31:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:AsthmaInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897695
Page 117 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK
/2013
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:31:30
(UTC-06:00) Central
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
Sep-24-2020 15:31:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-24-2020 15:31:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-24-2020 15:31:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-24-2020 15:31:56
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897696
Page 118 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Line/MH Nu
mber:4
Medical Hist
ory Term:Recurrent abd
ominal pain
Start Date: UNK/UNK/20
12
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:31:56
(UTC-06:00) Central
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
Sep-24-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent abdominal painInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-24-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-24-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897697
Page 119 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 15:32:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:Chronic const
ipation
Start Date: UNK/UNK/2
012
Ongoing: NO
End Date:
UNK/UN
K/2015Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897698
Page 120 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:32:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 15:32:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic constipationInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-24-2020 15:32:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-24-2020 15:32:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.f
Date Location User Value Reason
Sep-24-2020 15:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897699
Page 121 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:Hemorrhoi
ds
Start Date: UNK/UNK
/1998
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 15:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-24-2020 15:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-24-2020 15:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897700
Page 122 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-24-2020 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Cyst - bilatera
l breasts
Start Date: UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK
/2001Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897701
Page 123 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:33:50
(UTC-06:00) Central
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
Sep-24-2020 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cyst - bilateral breastsInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-24-2020 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-24-2020 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.h
Date Location User Value Reason
Sep-24-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897702
Page 124 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:Insomnia
Start Date: UNK/UNK
/2005
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:34:10
(UTC-06:00) Central
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
Sep-24-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-24-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-24-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897703
Page 125 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-24-2020 15:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical Hi
story Term:Bilateral carpal
tunnel syndrom
e
Start Date: UNK/UNK/200
6
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:34:40
(UTC-06:00) Central
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
Sep-24-2020 15:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral carpal tunnel syndr
omeInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-24-2020 15:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-24-2020 15:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897704
Page 126 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j
Date Location User Value Reason
Sep-24-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Osteoarthriti
s - knees
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897705
Page 127 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:35:13
(UTC-06:00) Central
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
Sep-24-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis - kneesInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-24-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-24-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897706
Page 128 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Sep-24-2020 15:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Osteoporos
is
Start Date: UNK/UNK
/2013
Ongoing: YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897707
Page 129 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:35:36
(UTC-06:00) Central
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
Sep-24-2020 15:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoporosisInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-24-2020 15:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-24-2020 15:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-24-2020 15:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Recurrent lu
mbar painInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897708
Page 130 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
010
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:36:06
(UTC-06:00) Central
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
Sep-24-2020 15:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent lumbar painInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-24-2020 15:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-24-2020 15:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-24-2020 15:36:29 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897709
Page 131 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Num
ber:13
Medical Histor
y Term:Anxiety
Start Date: UNK/UNK
/2001
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:36:29
(UTC-06:00) Central
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
Sep-24-2020 15:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-24-2020 15:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-24-2020 15:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897710
Page 132 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n
Date Location User Value Reason
Sep-24-2020 15:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Allergic rhi
nitis
Start Date: UNK/UNK
/1995
Ongoing: YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897711
Page 133 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:36:53
(UTC-06:00) Central
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
Sep-24-2020 15:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic rhinitisInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-24-2020 15:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-24-2020 15:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-24-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical Hi
story Term:Cystectomy - bi
lateral breastsInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897712
Page 134 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/200
1
Ongoing: NO
End Date:
UNK/UNK/
2001
1.o Line/MH Number:
Date Location User Value Reason
Sep-24-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cystectomy - bilateral breas
tsInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-24-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-24-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897713
Page 135 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-24-2020 15:37:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897714
Page 136 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
117.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
62.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897715
Page 137 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Mass Index:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21.2Initial Entry
7.a
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Locatio
n::EA
RInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897716
Page 138 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 15:38:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897717
Page 139 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897718
Page 140 of 316
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-24-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897719
Page 141 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-24-2020 15:39:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-24-2020 15:39:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
264155Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897720
Page 142 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 15:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 15:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
15:38:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
15:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-24-2020
15:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897721
Page 143 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-29-2020
02:14:54
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query.
Sep-28-2020
08:05:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-28-2020
08:05:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Sep-25-2020
09:11:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened DM: A carriage
is identified. To
avoid processing
errors, please
remove the
identified
character by
deleting the entry
and re-entering
the data (without
using copy and
paste).
Sep-24-2020
15:38:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
5.a
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897722
Page 144 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020
15:38:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98GTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
15:38:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98GTInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020
15:38:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWV5Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020
15:38:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWV5Initial Entry
5.c
Date Location User Value Reason
Sep-24-2020
15:38:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWV6Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897723
Page 145 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-24-2020
15:38:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWV6Initial Entry
5.d
Date Location User Value Reason
Sep-24-2020
15:39:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWV7Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-24-2020
15:39:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWV7Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897724
Page 146 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 15:39:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 15:39:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
15:39:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
15:39:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-24-2020
15:39:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897725
Page 147 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-24-2020
15:39:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98N1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
15:39:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98N1Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897726
Page 148 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020 13:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897727
Page 149 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Side:
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION 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-24-2020 15:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897728
Page 150 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-29-2020
01:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed by DM:
Sep-28-2020
08:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-28-2020
08:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUBJ
ECTTranscription
Error
Sep-25-2020
08:35:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Per Trial
Max, Subject is
not the subset of
'Reactogenicity
Diary collection'.
Please review and
consider to update
response for
'Reactogenicity
diary collection' as
'No', else clarify in
query response.
Thanks
Sep-24-2020
15:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICI
TY E-DIARY COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897729
Page 151 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 14:04:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897730
Page 152 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.1
Temperature Unit: F
Temperature Locatio
n::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.1Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897731
Page 153 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020 14:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897732
Page 154 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897733
Page 155 of 316
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-15-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897734
Page 156 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 16:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 16:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
16:55:23
(UTC-06:00) Central
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-15-2020
16:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897735
Page 157 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-15-2020
16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98T2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98T2Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897736
Page 158 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020 11:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897737
Page 159 of 316
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Side:
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-15-2020 14:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897738
Page 160 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Dec-23-2020 08:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Dec-11-2020 08:47:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Undeleted Changed
Information
Dec-10-2020 10:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Nov-06-2020 10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897739
Page 161 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897740
Page 162 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897741
Page 163 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:24:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897742
Page 164 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:25:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897743
Page 165 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:26:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897744
Page 166 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897745
Page 167 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897746
Page 168 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897747
Page 169 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-07-2020 13:37:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897748
Page 170 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-08-2020 09:49:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897749
Page 171 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-08-2020 09:51:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897750
Page 172 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-14-2020 07:23:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897751
Page 173 of 316
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-14-2020 07:39:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897752
Page 174 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020 10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020 10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-23-2020
19:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed closing an
answered query
on a closed AE
Dec-23-2020
08:45:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Since subject was
not the driver, the
AE will be closed.
Dec-17-2020
09:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opene
dCLINICAL SAE
event is Motor
Vehicle Collision;
however, SAE
report does not
have this; only
Injury due to
Pedestrian-car
accident. Subject
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897753
Page 175 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
was not the driver.
Please confirm if
this is an
additional
AE/SAE.
Dec-15-2020
11:47:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-14-2020
08:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Will remove
Motor Vehicle
Collision AE
Dec-11-2020
14:01:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened CLINICAL - As
subject was not a
driver, a separate
report of Motor
Vehicle Collision
is not required.
Serious Adverse
Event of
Pedestrian-car
accident is
reported.
Dec-11-2020
08:47:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered opened AE
Dec-11-2020
07:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opene
dqueries on a
closed AE
Dec-10-2020
10:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed
Information
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897754
Page 176 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-09-2020
10:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened CLINICAL SAE
event term is
Motor Vehicle
Collision;
however, SAE
report term is
Injury due to
Pedestrian-car
accident. Please
review, harmonize
reporting, and
update in the
appropriate
location.
Nov-11-2020
05:18:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed safety notified
and will continue
the FU.
Nov-10-2020
07:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered pending medical
records
Nov-10-2020
06:09:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened GPDCLIN: Per
CRF completion
guidelines, MVA
should be
recorded as an AE
when the
Participant is the
operator of the
vehicle. Please
confirm subject
was the driver and
clarify if
additional AEs
needs to be
reported as a
result of the
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897755
Page 177 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
accident.
Nov-09-2020
11:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for
requested info on
driver status
Nov-09-2020
09:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Information
unknown at the
moment. Will
update CRF once
info is known.
Nov-08-2020
12:33:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical If the
subject driving
and a MVA
occurred, MVA
needs to be
reported recorded
as AEs as well
(see specific CRF
completion
guidelines
8.50.2.1 - MVA
should be
recorded as an AE
when the
Participant is the
operator of the
vehicle)
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Motor Vehicle CollisionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-07-2020 ACV0PFEINFP6000 Data Entry: Transcription
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0897756
Page 178 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
09:36:52
(UTC-06:00) Central
Time (US & Canada)Nov/4/2020 UNK:UNK Error
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-17-2020
09:21:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed other query
issued
Dec-11-2020
14:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Dec-11-2020
08:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Opened AE
Dec-11-2020
08:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Opened AE
Dec-11-2020
07:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened queries on a
closed AE
Dec-11-2020
07:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened queries on a
closed AE
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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) (4), (b) (6)
FDA-CBER-2021-5683-0897757
Page 179 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-10-2020
10:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed
Information
Dec-10-2020
10:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Dec-09-2020
10:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened CLINICAL If
subject has been
discharged from
Hosp to home or
other facility,
please update
Hospital end date
in SAE report;
also report if
ventilator
dependency still
persists
Dec-09-2020
10:15:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened CLINICAL
Thank you.
Please submit the
SAE end date of
04Nov2020 in a
SAE safety
update report.
Dec-08-2020
19:18:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-07-2020
09:36:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto
Query
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897758
Page 180 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-07-2020
09:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For Motor
Vehicle Collision
End Date & Time
04/Nov/2020
UNK:UNK is
before the Start
Date & Time
05/Nov/2020
UNK:UNK.
Dec-07-2020
09:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Dec-07-2020
09:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-07-2020
09:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/4/2020 UNK:UN
KNew Information
Dec-06-2020
13:57:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL SAE
report states as of
24Nov20, subject
did not appear on
the hospital
roster. Can it be
confirmed that
subject was
discharged, in
contrast with a
possible death
Dec-01-2020
20:21:22ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Please record an
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897759
Page 181 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-06:00) Central
Time (US & Canada)end date for the
motor vehicle
collision and, as
per CRF
completion
guidelines, record
any associated
injuries as
separate AE
entries
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020
10:44:43 (UTC-06:00)
Central 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
Dec-17-2020
10:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed closing old query
Dec-17-2020 ACV0PFEINFP6000 Query 6: Closed closing old query
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0897760
Page 182 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10:07:34
(UTC-06:00) Central
Time (US & Canada)
Dec-11-2020
08:48:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered Opened AE
Dec-11-2020
08:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered Opened AE
Dec-11-2020
07:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Reissued:Opened queries on a
closed AE
Dec-11-2020
07:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Reissued:Opened queries on a
closed AE
Dec-10-2020
08:55:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6: Answered AE form has
been updated to
harmonize both
AE and SAE
forms.
Dec-10-2020
08:55:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered AE form has
been updated to
harmonize both
AE and SAE
forms.
Dec-10-2020
08:55:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event assoc
iated with congenital ano
maly or birth defect?AE form has
been updated to
harmonize both
AE and SAE
forms.
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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) (6)
FDA-CBER-2021-5683-0897761
Page 183 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importan
t serious event
NO
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897762
Page 184 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
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
Dec-09-2020
10:17:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 6: Reissued:
OpenedClinical Thank you. Please
enter a test date in the SAE
lab section for the COVID
test during hospitalization,
if date is known
Dec-09-2020
10:14:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 5: Reissued:
OpenedCLINICAL Thank you.
The 08Dec SAE update
continues to report 2
serious criteria for event of
pedestrian/car accident
(Hospitalization and
Life-threatening). Please
update either AE or SAE to
harmonize.
Dec-09-2020
04:59:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies query
Dec-07-2020
14:09:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 6: Answere
dTest status has been
included on form submitted
today.
Dec-07-2020
14:09:14ACV0PFEINFP6000 Query 5: Answere
dFollow up SAE form has
been submitted
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897763
Page 185 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-06:00)
Central Time (US
& Canada)harmonizing the report.
Thank You.
Dec-07-2020
13:39:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Answere
dFollow up AE form has
been updated to reflect
'injury secondary to
pedestrian-car accident'
Dec-06-2020
13:53:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 6: Opened CLINICAL Followup -
Covid test status (Yes/No
or not performed) was not
included in the 24Nov20
update; please submit if
available.
Dec-06-2020
13:50:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 5: Opened CLINICAL Serious criteria
for event of Motor Vehicle
Accident is
Hospitalization; however,
SAE criteria include Hosp
and Life-threatening.
Please review, harmonize
reporting, and update in the
appropriate location.
Dec-02-2020
06:34:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed new query issued
Dec-02-2020
06:33:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Opened SAE
RECON:AER#2020431728
motor vehicle collision was
recorded in both database
however, Injury secondary
to pedestrian-car accident
was recorded as a separate
event in Safety
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0897764
Page 186 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
database.Please submit a
follow up AEM form to
clarify event term.
Dec-02-2020
06:29:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:
OpenedFor PSSR review
Dec-01-2020
15:08:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dThis is an updated term for
'motor vehicle collision'.
Dec-01-2020
05:51:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:
OpenedSAE RECON 1:In safety
database,another SAE with
term 'Injury secondary to
pedestrian-car accident'was
recorded. Please confirm if
this is an updated term for
motor vehicle collision or it
should be recorded as
separate SAE in CRF.
Nov-30-2020
09:14:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dplease clarify. Marked as
serious in AE CRF
Nov-25-2020
05:32:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2020431728
Injury secondary to
pedestrian-car
accident(onset
date:05Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897765
Page 187 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Nov-10-2020
22:29:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will follow
for SAE update with the
requested COVID test info
Nov-10-2020
11:04:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answere
dsae submitted to state
negative covid test
Nov-10-2020
10:35:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID test status
(yes/no) during
Hospitalization has not
been reported in the SAE
submitted to safety. Please
submit a follow-up SAE
form [#2020431728] to
document if COVID testing
was performed (YES/NO)
and if yes, the date and
results.
Nov-07-2020
08:41:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-07-2020
04:16:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened For AE Motor Vehicle
Collision: Response to "Is
the adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number" is
blank.
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897766
Page 188 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-06-2020
10:44:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eFor AE Motor Vehicle
Collision: Response to "Is
the adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number" is
blank.
Nov-06-2020
10:44:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious eve
nt associated with
congenital anoma
ly or birth defect?
NO
Did this serious e
vent result in deat
h?
NO
Did this serious e
vent require or pr
olong hospitalizat
ion?
YES
Did this serious e
vent result in pers
istent or significa
nt disability/inca
pacity?
NO
Is this serious eve
nt life threatening
?Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897767
Page 189 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
Other medically i
mportant 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.
Date Location User Value Reason
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
Vehicle CollisionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0897768
Page 190 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10:44:43
(UTC-06:00) Central
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-07-2020
10:15:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Cl
osedClose Auto Query
Dec-07-2020
10:15:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
RECOVER
ED/RESOL
VED WITH
SEQUELA
ENew Information
Dec-07-2020 ACV0PFEINFP6000 auto query Query 5: Op For AE Motor Vehicle Collision:
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897769
Page 191 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
09:36:25
(UTC-06:00)
Central Time
(US & Canada)(autoquery) ened Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Nov-27-2020
01:58:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Cl
osedResponse satisfies query
Nov-26-2020
19:35:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Cl
osedResponse satisfies query
Nov-26-2020
17:18:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: An
sweredNew Information
Nov-26-2020
17:18:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: An
sweredAnswer Auto Query
Nov-26-2020
17:18:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
NOT RECO
VERED/NO
T RESOLV
EDNew Information
Nov-26-2020
04:15:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Op
enedSAE RECON:AER#2020431728
,outcome was updated to Not
Recovered/Not Resolved on Safety
database while reported as
'UNKNOWN' in AE CRF . Please
confirm correct outcome. If safety
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897770
Page 192 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
update is required, please submit a
follow-up form.
Nov-24-2020
02:40:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Re
issued:Open
edDM: Response to "What was the
outcome of this adverse event?" is
'Unknown', However "Is the adverse
event still ongoing?" is marked
"Yes", as per previous response
medical records will be available by
23 NOV 2020, please review and
update, else clarify.
Nov-17-2020
11:55:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Re
issued:Cand
idatePossibly receiving medical records
23 NOV 2020. Will update then
Nov-17-2020
07:42:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: An
sweredPossibly receiving medical records
23 NOV 2020. Will update then
Nov-15-2020
12:20:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Re
issued:Open
edIn order to put this issue on hold we
need an date (or estimated date) as to
when the missing information is
available. Please provide a DATE as
to when we can expect the
information. Thank you!
Nov-13-2020
14:12:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
osedResponse satisfies query
Nov-13-2020
14:11:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Re
issued:Cand
idateAwaiting medical records to update
Outcome.
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0897771
Page 193 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-13-2020
08:56:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: An
sweredMedical records are pending. Unbale
to reach subject at this time.
Nov-13-2020
08:45:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Op
enedFor AE Motor Vehicle Collision:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
marked "Yes".
Nov-13-2020
08:45:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: An
sweredTranscription Error
Nov-13-2020
08:45:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
UNKNOW
NTranscription Error
Nov-12-2020
04:01:56
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Op
enedSAE
RECON:AER#2020431728,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Nov-10-2020
16:13:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies query
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897772
Page 194 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-10-2020
07:47:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredAnswer Auto Query
Nov-10-2020
07:47:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
NOT RECO
VERED/NO
T RESOLV
EDTranscription Error
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897773
Page 195 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-10-2020
02:32:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dAE is still
ongoing and AE
Outcome is not
recorded as
Unresolved or
Resolving.
Please reconcile
and update data;
else clarify
Nov-09-2020
09:52:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Medical records
have been
requested. Will
update once
information is
known.
Nov-07-2020
08:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dRQ#1: AE is till
ongoing and AE
Outcome is not
recorded as
Unresolved or
Resolving.
Please reconcile
and update data;
else clarify.
Nov-06-2020
11:42:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered ongoing
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Motor
Vehicle
Collision:
Response to
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897774
Page 196 of 316
***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, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
"What was the
outcome of this
adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is
the adverse event
still ongoing?" is
marked "Yes".
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
10:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-07-2020 08:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020431728Initial Entry
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897775
Page 197 of 316
***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, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-07-2020 13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-07-2020 13:16:54
(UTC-06:00) Central
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
Jan-20-2021
05:26:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Jan-19-2021
13:44:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-19-2021
13:44:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Small Parafalcine S
ubdural hematomaTranscription Error
Jan-11-2021
05:52:02ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020431728,
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897776
Page 198 of 316
***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, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)the term in Safety was
updated to 'Small
parafalcine SUBDURAL
hematoma' while retained as
Small Parafalcine
Subdermal hematoma in
CRF. Please confirm correct
term. If safety update is
required, please submit a
follow-up form
Dec-07-2020
13:16:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Small Parafalcine S
ubdermal hematomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021
18:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-10-2021
11:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Event updated in
SAE safety
update.
Feb-10-2021
10:51:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank
you; please
submit event end
date in a SAE
safety update
Feb-04-2021
09:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Form updated.
Feb-01-2021 ACV0PFEINFP6000 Query 1: Opened Clinical Please
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0897777
Page 199 of 316
***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, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
18:25:52
(UTC-06:00) Central
Time (US & Canada)review for end
date of this
event, which is
still listed at
Grade 3
Dec-07-2020
13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-04-2021
09:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/3/2020 UNK:UNKTranscription
Error
Dec-07-2020
13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-07-2020
13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0897778
Page 200 of 316
***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, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Dec-17-2020
08:45:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-11-2020
08:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered SAE form
updated.
Dec-11-2020
07:04:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened CLINICAL -
Event serious
criteria is Hosp;
however, SAE
event report has
serious criteria of
Hosp and
Life-threatening.
Please review,
harmonize
reporting, and
update in the
appropriate
location.
Dec-11-2020
07:03:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-11-2020
03:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020
15:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered SAE report
submitted
10Dec2020
Dec-09-2020 ACV0PFEINFP6000 Query 3: Opened CLINICAL
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (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) (6)
FDA-CBER-2021-5683-0897779
Page 201 of 316
***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, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10:36:17
(UTC-06:00) Central
Time (US & Canada)Subdural
hematoma event
should be
independently be
considered for
Serious criteria. If
Serious, please add
to SAE report
#2020431728 in
the SAE section as
a SAE (event is
already in the
narrative; thank
you), otherwise
modify Serious
criteria
Dec-09-2020
10:34:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed rewording
Dec-09-2020
10:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Event
of subdural
hematoma is
Serious; please add
to current SAE
report
#2020431728 in
the SAE section as
SAE #2
(hematoma is
already in the
narrative; thank
you).
Dec-07-2020
13:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Small
Parafalcine
Subdermal
hematoma:
Response to "Is the
adverse event
090177e196ae3e29\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0897780
Page 202 of 316
***Confidential***
Header Text: c4591001
Visit:
…[truncated]