Document text
Page 1 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135461
Page 2 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135462
Page 3 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10121112]
2.Birth Date: /1940
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135463
Page 4 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135464
Page 5 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135465
Page 6 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135466
Page 7 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PROSTATE CANCER]
Start Date: Dec/UNK/1987
Ongoing: NO
End Date:
Dec/UNK/1987
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PROSTATECTOMY]
Start Date: Dec/UNK/1987
Ongoing: NO
End Date:
UNK/UNK/1987
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SQUAMOUS CELL CARCINOMA ON FACE]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135467
Page 8 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VASECTOMY]
Start Date: UNK/UNK/1977
Ongoing: NO
End Date:
UNK/UNK/1977
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT KNEE REPLACEMENT]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GENERALIZED OSTEOARTHRITIS]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135468
Page 9 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heart Arrhythmia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Loop Recorder Implant]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mitral Valve Prolapse]
Start Date: UNK/UNK/2017
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral hearing loss]
Start Date: UNK/UNK/1964
Ongoing: YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135469
Page 10 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [170.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135470
Page 11 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249283]
3.Randomization Group: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135471
Page 12 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP43SP]
5.bSample ID [BPL1R4]
5.cSample ID [BPL1R5]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135472
Page 13 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP43SN]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135473
Page 14 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 11:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135474
Page 15 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135475
Page 16 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135476
Page 17 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135477
Page 18 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP4413]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135478
Page 19 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/21/2020 13:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135479
Page 20 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135480
Page 21 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BPL25G]
5.bSample ID [BPL25H]
5.cSample ID [BP9JCK]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135481
Page 22 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135482
Page 23 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/3/2020
2.Date of First Symptom Started: Dec/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/2/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135483
Page 24 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135484
Page 25 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/2/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135485
Page 26 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [COVID-19 Swab/Non-Swab (SQ); Sonora Quest Laboratories]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135486
Page 27 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV20598]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135487
Page 28 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Telehealth]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135488
Page 29 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [Testing facility]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135489
Page 30 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135490
Page 31 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135491
Page 32 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135492
Page 33 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135493
Page 34 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135494
Page 35 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135495
Page 36 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135496
Page 37 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135497
Page 38 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135498
Page 39 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135499
Page 40 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135500
Page 41 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135501
Page 42 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 43 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135503
Page 44 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135504
Page 45 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135505
Page 46 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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.Start Date: //
6.Ongoing?
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 47 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135507
Page 48 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 49 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135509
Page 50 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/30/2020
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 [BP9JHJ]
5.bSample ID [BRYKJX]
5.cSample ID [BRYKJY]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135510
Page 51 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135511
Page 52 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135512
Page 53 of 246
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135513
Page 54 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135514
Page 55 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135515
Page 56 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135516
Page 57 of 246
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 PAROXYSMAL ATRIA
L FIBRILLATION Dec/9/2020 U
NK:UNK NO
End Date Time:
Dec/11/2020 UNK
:UNK
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 DIZZINESS Dec/9/2020 U
NK:UNK NO
End Date Time:
Dec/11/2020 UNK
:UNK
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 HEART PALPITATION
S Dec/9/2020 U
NK:UNK NO
End Date Time:
Dec/11/2020 UNK
:UNK
Repeating
Pages
4. DELETED ADVERSE
EVENT 4 TACHYCARDIA Dec/9/2020 U
NK:UNK NO
End Date Time:
Dec/11/2020 UNK
:UNK
Repeating
Pages
5. ADVERSE
EVENT 5 BODY CHILLS Feb/3/2021 U
NK:UNK NO
End Date Time:
Feb/6/2021 UNK:
UNK
Repeating
Pages
6. ADVERSE
EVENT 6 BODY SWEATS Feb/3/2021 U
NK:UNK NO
End Date Time:
Feb/6/2021 UNK:
UNK
Repeating
Pages
7. ADVERSE
EVENT 7 BACK PAIN Feb/3/2021 U
NK:UNK YES Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135517
Page 58 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[PAROXYSMAL ATRIAL FIBRILLATION]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 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
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
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135518
Page 59 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
[New diagnosis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020492668]
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Page 60 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[DIZZINESS ]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 61 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135521
Page 62 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[HEART PALPITATIONS ]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 63 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135523
Page 64 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[TACHYCARDIA ]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
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Page 65 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135525
Page 66 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[BODY CHILLS]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/6/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 68 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[BODY SWEATS]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/6/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 69 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135529
Page 70 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[BACK PAIN]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135530
Page 71 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135531
Page 72 of 246
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
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FDA-CBER-2021-5683-0135533
Page 74 of 246
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicati
onStart Da
teForm Instanc
e
1.1 VACCINATIONS
NO Seasonal Influenza
Vaccine Oct/16/2
020 Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135534
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Seasonal Influenza Vaccine]
5.Date: Oct/16/2020
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***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135536
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
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***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
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***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
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FDA-CBER-2021-5683-0135540
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135541
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***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0135543
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135544
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***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135545
Page 86 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135546
Page 87 of 246
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135547
Page 88 of 246
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135548
Page 89 of 246
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135549
Page 90 of 246
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135550
Page 91 of 246
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135551
Page 92 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135552
Page 93 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135553
Page 94 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135554
Page 95 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135555
Page 96 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYKKK]
5.bSample ID [BRYKKL]
5.cSample ID [BP9JJC]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135556
Page 97 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9JJB]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135557
Page 98 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 16:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135558
Page 99 of 246
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135559
Page 100 of 246
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8XCM]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135560
Page 101 of 246
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 11:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135561
Page 102 of 246
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135562
Page 103 of 246
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/2/2021
3.Comments: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135563
Page 104 of 246
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135564
Page 105 of 246
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135565
Page 106 of 246
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135566
Page 107 of 246
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135567
Page 108 of 246
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135568
Page 109 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135569
Page 110 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135570
Page 111 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135571
Page 112 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-03-2020 19:14:37 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject met all inclusion/exclusion criteria
Not Applicable
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135572
Page 113 of 246
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-14-2021 15:46:37 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Met criteria to continue
Not Applicable
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135573
Page 114 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Sahara Vega N/A Feb-03-2021 09:36:54 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Jan-25-2021 12:28:07 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
Sahara Vega N/A Jan-25-2021 09:46:33 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Jan-22-2021 09:04:50 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135574
Page 115 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sahara Vega N/A Dec-18-2020 18:11:25 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Dec-10-2020 13:53:07 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
Sahara Vega N/A Dec-09-2020 15:19:39 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Dec-09-2020 12:54:02 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
Sahara Vega N/A Dec-03-2020 11:04:36 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135575
Page 116 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Matthew Doust Approved Oct-26-2020 16:24:00 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135576
Page 117 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 18:46:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 18:46:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135577
Page 118 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 19:13:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135578
Page 119 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 18:46:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10121112Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 18:45:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1940Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 19:14:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 19:14:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 19:14:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
WHITEInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135579
Page 120 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 19:14:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/2/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135580
Page 121 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 19:15:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 19:15:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 19:15:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
COMPLETEDInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135581
Page 122 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 13:41:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:PROSTATE CA
NCER
Start Date: Dec/UNK/1987
Ongoing: NO
End Date:
Dec/UNK/19
87Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Feb-22-2021 13:11:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 2: Closed Response satisfies
query
Feb-22-2021 11:39:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Query 2: Answered Changed data per
query
Feb-05-2021 17:19:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 2: Opened Per hospital
discharge summary
dated 12/11/20
subject had PMH
significant for
Arrhythmia s/p
implantable loop
recorder 10/2019,
mitral valve
prolapse with
regurgitation, sleep
apnea and
tachycardia, please
revisit and update
the medical history
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135582
Page 123 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-27-2021 11:03:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Closed DQ added to the
MH page
Jan-27-2021 10:48:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Opened Per Discharge
summary from
Honor Health for
the SAE this pt had
a history of
Arrhythmia and
loop recorder
implant since
October 2019,
Mitral Valve
prolapse since
2017. Please revisit
and update the
medical history
eCRF page as
needed.
Sep-16-2020 13:41:32
(UTC-07:00) Mountain
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-16-2020 13:41:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
PROSTATE CANCERInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 13:41:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Dec/UNK/1987Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 13:41:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
End Date:Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135583
Page 124 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec/UNK/1987
1.b
Date Location User Value Reason
Sep-16-2020 13:42:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:PROSTATECT
OMY
Start Date: Dec/UNK/1987
Ongoing: NO
End Date:
UNK/UNK/
1987Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135584
Page 125 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:42:11
(UTC-07:00) Mountain
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-16-2020 13:42:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
PROSTATECTOMYInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 13:42:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Dec/UNK/1987Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 13:42:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
End Date:
UNK/UNK/1987Initial Entry
1.c
Date Location User Value Reason
Sep-16-2020 13:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:SQUAMOUS CELL
CARCINOMA ON F
ACE
Start Date
:UNK/UNK/2018Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135585
Page 126 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
UNK/UNK/2018
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:42:47
(UTC-07:00) Mountain
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-16-2020 13:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
SQUAMOUS CELL CARCIN
OMA ON FACEInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020 13:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020 13:42:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.d
Date Location User Value Reason
Sep-16-2020 13:43:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135586
Page 127 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History
Term:HYPERLIPID
EMIA
Start Date: UNK/UNK/20
17
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:43:03
(UTC-07:00) Mountain
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-16-2020 13:43:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
HYPERLIPIDEMIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020 13:43:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020 13:43:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-16-2020 13:43:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:VASECTOMYInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135587
Page 128 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Start Date: UNK/UNK/197
7
Ongoing: NO
End Date:
UNK/UNK/
1977
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:43:23
(UTC-07:00) Mountain
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-16-2020 13:43:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
VASECTOMYInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020 13:43:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/1977Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020 13:43:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
End Date:
UNK/UNK/1977Initial Entry
1.f
Date Location User Value Reason
Sep-16-2020 13:43:48 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135588
Page 129 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-07:00) Mountain
Time (US & Canada)(autocalc) Line/MH Num
ber:6
Medical Histor
y Term:SEASONAL AL
LERGIES
Start Date: UNK/UNK/2010
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:43:48
(UTC-07:00) Mountain
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-16-2020 13:43:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
SEASONAL ALLERGIESInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-16-2020 13:43:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-16-2020 13:43:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-16-2020 13:44:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135589
Page 130 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical Hist
ory Term:LEFT KNEE REP
LACEMENT
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/201
4
1.g Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:44:20
(UTC-07:00) Mountain
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-16-2020 13:44:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
LEFT KNEE REPLACEMENTInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-16-2020 13:44:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-16-2020 13:44:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.h
Date Location User Value Reason
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135590
Page 131 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020 13:48:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:GENERALIZED O
STEOARTHRITIS
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Sep-16-2020 13:48:55
(UTC-07:00) Mountain
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-16-2020 13:48:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
GENERALIZED OSTEOART
HRITISInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-16-2020 13:48:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-16-2020 13:48:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Feb-22-2021 11:37:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Line/MH Numb
er:9Changed
Information
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135591
Page 132 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History
Term:Heart Arrhyt
hmia
Start Date: UNK/UNK/
2019
Ongoing: YES
Feb-22-2021 11:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Arrhythmia
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Feb-22-2021 11:35:33
(UTC-07:00) Mountain
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
Feb-22-2021 11:37:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Heart ArrhythmiaChanged
Information
Feb-22-2021 11:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
ArrhythmiaInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135592
Page 133 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.i Start Date:
Date Location User Value Reason
Feb-22-2021 11:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
UNK/UNK/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Feb-22-2021 11:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Feb-22-2021 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Loop Recorder I
mplant
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/20
19Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135593
Page 134 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.j Line/MH Number:
Date Location User Value Reason
Feb-22-2021 11:36:01
(UTC-07:00) Mountain
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
Feb-22-2021 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Loop Recorder ImplantInitial Entry
1.j Start Date:
Date Location User Value Reason
Feb-22-2021 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Oct/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Feb-22-2021 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.k
Date Location User Value Reason
Feb-22-2021 11:36:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Mitral Valve Pr
olapse
Start Date: UNK/UNK/201
7
Ongoing: YESInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135594
Page 135 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.k Line/MH Number:
Date Location User Value Reason
Feb-22-2021 11:36:43
(UTC-07:00) Mountain
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
Feb-22-2021 11:36:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Mitral Valve ProlapseInitial Entry
1.k Start Date:
Date Location User Value Reason
Feb-22-2021 11:36:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Feb-22-2021 11:36:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Feb-22-2021 11:37:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:Bilateral hearin
g loss
Start Date: UNK/UNK/19
64
Ongoing: YESInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135595
Page 136 of 246
***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, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.l Line/MH Number:
Date Location User Value Reason
Feb-22-2021 11:37:03
(UTC-07:00) Mountain
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
Feb-22-2021 11:37:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
Bilateral hearing lossInitial Entry
1.l Start Date:
Date Location User Value Reason
Feb-22-2021 11:37:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
UNK/UNK/1964Initial Entry
1.l Ongoing:
Date Location User Value Reason
Feb-22-2021 11:37:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madison
Mikulak
(pfe mmikulak)Data Entry:
YESInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135596
Page 137 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
170.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.1Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135597
Page 138 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 19:15:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135598
Page 139 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 19:16:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 19:16:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
249283Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135599
Page 140 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 19:16:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 19:16:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-06-2020 10:17:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-04-2020 01:17:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 19:16:11
(UTC-07:00) Mountain
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-03-2020 19:16:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135600
Page 141 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-06-2020 10:17:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP43SPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-06-2020 10:17:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP43SPInitial Entry
5.b
Date Location User Value Reason
Sep-06-2020 10:17:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL1R4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-06-2020 10:17:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL1R4Initial Entry
5.c
Date Location User Value Reason
Sep-06-2020 10:17:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL1R5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-06-2020 10:17:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL1R5Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135601
Page 142 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 19:16:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 19:16:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-06-2020 10:18:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-04-2020 01:18:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 19:16:22
(UTC-07:00) Mountain
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-03-2020 19:16:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135602
Page 143 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-06-2020 10:18:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP43SNInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-06-2020 10:18:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP43SNInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135603
Page 144 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/2/2020 11:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) MountainACV0PFEINFP6000 Selma
LeudtkeData Entry:
LEFTInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135604
Page 145 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.sleudtke)
7. Route:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135605
Page 146 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 19:16:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135606
Page 147 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 16:02:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135607
Page 148 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Record Identifier:
:1
Temperature: 96.7
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 01:18:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Sep-29-2020 16:57:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Shana
Harshell
(pfe.sharshell)Query 1: Answered CONFIRM TEMP
IS CORRECT
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.7 F
is outside of
Normal Range 97 -
99.5 F.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135608
Page 149 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
96.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 16:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135609
Page 150 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 16:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 16:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 16:16:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 01:49:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-21-2020 16:02:49
(UTC-07:00) Mountain
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-21-2020 16:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135610
Page 151 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-29-2020 16:16:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Shana
Harshell
(pfe.sharshell)Data Entry:
Sample ID: BP4413Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:16:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Shana
Harshell
(pfe.sharshell)Data Entry:
BP4413Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135611
Page 152 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020 13:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) MountainACV0PFEINFP6000 Selma
LeudtkeData Entry:
LEFTInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135612
Page 153 of 246
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.sleudtke)
7. Route:
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-21-2020 16:04:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135613
Page 154 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 15:13:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Oct/20/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135614
Page 155 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 15:13:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:13:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 04:34:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-20-2020 15:13:28
(UTC-07:00) Mountain
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-20-2020 15:13:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135615
Page 156 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-21-2020 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL25GInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 11:36:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL25GInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020 11:36:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL25HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 11:36:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL25HInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 11:36:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP9JCKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 11:36:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP9JCKInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135616
Page 157 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 14:18:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 5: Closed Response satisfies
query
Jan-29-2021 08:17:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 5: Answered Changed data per
query
Jan-25-2021 15:25:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 5: Reissued:Opened HOLDS: For
Convalescent A1
visit, the lab has
received serum
sample barcode
BP9JHJ; however,
the BARCODE nor
visit data have been
recorded. Please
review and update
as appropriate.
Otherwise please
clarify update?
Jan-25-2021 09:47:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 5: Answered Changed data per
query
Jan-13-2021 13:01:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Jennifer Riddle
(pfe riddlj)Query 5: Opened HOLDS: For
Convalescent A1
visit, the lab has
received serum
sample barcode
BP9JHJ; however,
the barcode nor
visit data have been
recorded. Please
review and update
as appropriate.
Otherwise please
clarify.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135617
Page 158 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-19-2020 08:42:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 4: Closed SAE noted to be
entered in AE log
Dec-18-2020 15:13:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 4: Opened Subject is noted to
have a reported an
episode of Atrial
Fibrillation (12/20
/20?), please revisit
and update the EDC
as soon possible
and upload the
source in Florence.
Dec-11-2020 00:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 3: Closed Response satisfies
query
Dec-10-2020 12:19:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 3: Answered Changed data per
query
Dec-08-2020 04:19:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 3: Opened DM: Kindly review
and complete
‘Microbiology
Specimen form' at
this visit. Thank
you.
Dec-03-2020 11:08:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-03-2020 11:04:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-03-2020 11:04:35 ACV0PFEINFP6000 auto query Query 1: Candidate Date of Visit is
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135618
Page 159 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-07:00) Mountain
Time (US & Canada)(autoquery) completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-03-2020 11:04:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Dec/3/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-03-2020 11:04:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135619
Page 160 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Dec/3/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Dec/2/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NO
Date of Last Symptom Resolved:
Dec/2/2020Initial Entry
4.a
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135620
Page 161 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135621
Page 162 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.c Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Jan-14-2021 09:28:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINTranscription Error
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135622
Page 163 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Symptom
Present:YES
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-19-2021 11:17:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Closed Response satisfies
query
Jan-14-2021 09:28:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-14-2021 09:28:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YESTranscription Error
Dec-19-2020 08:33:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Opened per source dated
12/3/20 Muscle
aches is noted.
Please revisit and
update as needed.
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135623
Page 164 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135624
Page 165 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.g Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135625
Page 166 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.i Symptoms:
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-03-2020 11:05:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135626
Page 167 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135627
Page 168 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Dec/2/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) MountainACV0PFEINFP6000 Sahara
VegaData Entry:
OTHERInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135628
Page 169 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.svega)
7. Test Result:
Date Location User Value Reason
Jan-19-2021 11:16:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Closed source uploaded
noted and
confirmed the
results.
Jan-14-2021 10:47:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Dec-19-2020 08:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Opened Covid test results
are unable for
verification, please
upload in Florence.
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
NEGATIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
COVID-19 Swab/Non-Swab (SQ);
Sonora Quest LaboratoriesInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-09-2020 15:19:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NALT UnknownInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135629
Page 170 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 11:08:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 11:08:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 08:41:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-04-2020 00:28:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-03-2020 11:08:50
(UTC-07:00) Mountain
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.
Dec-03-2020 11:08:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135630
Page 171 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Dec-07-2020 08:41:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: CV20598Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 08:41:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
CV20598Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135631
Page 172 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 11:09:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 11:09:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 11:09:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-03-2020 11:09:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
TelehealthInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135632
Page 173 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135633
Page 174 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135634
Page 175 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135635
Page 176 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:OTHER
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135636
Page 177 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 11:24:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened “Other” is selected ,
however other
specific item is
blank. Please review
and update as
appropriate.
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Dec-03-2020 11:24:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Testing facilityInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-03-2020 11:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135637
Page 178 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/03/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-03-2020 11:23:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-03-2020 11:23:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-03-2020 11:23:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
1Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135638
Page 179 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Dec/30/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-14-2021 10:48:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
COVID_A1Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135639
Page 180 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021 10:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021 10:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-14-2021 21:18:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-14-2021 10:48:57
(UTC-07:00) Mountain
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.
Jan-14-2021 10:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YES
Date of Collection:
Dec/30/2020Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135640
Page 181 of 246
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Jan-25-2021 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP9JHJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021 09:46:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP9JHJInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021 09:47:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BRYKJXInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021 09:47:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BRYKJXInitial Entry
5.c
Date Location User Value Reason
Jan-25-2021 09:47:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BRYKJYInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-25-2021 09:47:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BRYKJYInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135641
Page 182 of 246
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020 15:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 15:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 15:13:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
COMPLETEDInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135642
Page 183 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135643
Page 184 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-25-2021 10:17:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Deleted Secondary to ae
#1
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135644
Page 185 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-25-2021 10:16:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Deleted Secondary to ae
#1
Dec-18-2020 18:13:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135645
Page 186 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-25-2021 10:18:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Deleted Secondary to ae
#1
Jan-25-2021 10:17:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Undeleted Transcription
Error
Jan-25-2021 10:13:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Deleted Secondary to ae
#1
Dec-18-2020 18:14:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135646
Page 187 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-08-2021 13:38:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135647
Page 188 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-08-2021 13:38:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135648
Page 189 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-08-2021 13:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135649
Page 190 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020 15:56:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Closed Response satisfies
query
Dec-22-2020 16:19:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Query 1: Answered Relevant medical
records have been
uploaded to
Florence.
Dec-19-2020 08:44:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Opened unable to verify
SAE details as no
source note to be
e-Source in
Florence. Please
upload all relevant
source asap.
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
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
Feb-16-2021 16:01:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Jan-29-2021 08:20:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Subject confirmed
not hispanic. SAE
follow-up has been
sent.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135650
Page 191 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-27-2021 17:37:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical Ethnicity
was reported as 'Not
Hispanic' on
Demography CRF,
recorded at the
consent visit.
Jan-25-2021 09:49:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Ethnicity will be
addressed at next
visit, 102
Dec-22-2020 10:05:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
submit a SAE
safety update to
report the subject's
ethnicity
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
PAROXYSMAL ATRIAL FIB
RILLATIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 16:01:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Jan-29-2021 08:20:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered SAE follow-up
report with new
start date has been
faxed as of 1/26/21
Jan-27-2021 17:38:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical Thank you.
Please submit a
SAE safety FAX to
update the SAE
start date to
09Dec20 in the
SAE as well.
Jan-25-2021 09:52:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Jan-25-2021 09:52:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Dec/9/2020 UNK:UNKChanged
Information
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135651
Page 192 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-22-2020 09:57:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical In Vaccine
study, SAE start
date is day event
starts; not day it
meets serious
criteria (item 11 in
vaccine SAE
instruct). If SAE
event began as
non-serious, record
the onset date as the
date the non-serious
event/event
symptoms began.
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Dec/10/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-05-2021 17:21:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Closed new query posted in
MH page &
unlocked
Jan-27-2021 17:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Opened Clinical The Med
Hx CRF is currently
unfrozen.
Jan-25-2021 09:59:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Please unfreeze page
to add new med
history.
Dec-23-2020 16:09:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Opened per Hospital
discharge summary
dated
12/11/20,subject has
a PMH significant
for arrhythmia s/p
implantable loop
recorder 10/2019,
mitral valve
0prolapse with
regurgitation, sleep
apnea and
tachycardia, please
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135652
Page 193 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
revisit and update
medical history
eCRF
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
NO
End Date Time:
Dec/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 16:02:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed SAE update has
results of Dec 20,
2020 COVID test
Jan-29-2021 08:23:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered SAE update 26jan21
does have this
information. see
page 7 of 8. Listed
under laboratory
tests (RELEVANT
TESTS).
Jan-27-2021 17:41:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical Thank you;
however, SAE
update (26Jan21) did
not include a COVID
test, with date and
result. Please submit
to SAE.
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135653
Page 194 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-25-2021 10:44:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered Negative. Is being
provided on sae
follow-up sent today
Dec-22-2020 10:04:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020492668] to
document if COVID
testing was
performed in
hospital (YES/NO or
info not available)
and if yes, the date
and results.
Dec-22-2020 04:28:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
PAROXYSMAL
ATRIAL
FIBRILLATION:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NOInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135654
Page 195 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious 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
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-23-2020 00:25:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Lina Gaikwad
(pfe.gaikwl)Query 1: Closed Response satisfies
query
Dec-22-2020 21:09:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Dec-22-2020 16:21:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Dec-22-2020 16:21:24
(UTC-07:00) MountainACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135655
Page 196 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
Dec-22-2020 16:21:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
New diagnosisInitial Entry
Dec-22-2020 10:03:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL Event
Relationship to
study treatment is
missing; however,
SAE report states
that there was not a
reasonable
possibility that
event A fib was
related to study
treatment. Please
review, harmonize
reporting, and
update where
required
Dec-20-2020 22:42:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is
missing. Kindly
review and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135656
Page 197 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 18:11:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020 04:28:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020492668Initial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135657
Page 198 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
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
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
DIZZINESSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Dec/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NO
End Date Time:
Dec/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135658
Page 199 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-25-2021 15:10:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Closed Response satisfies
query
Jan-25-2021 10:16:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-25-2021 10:16:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135659
Page 200 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Other, specify:
unknown
Dec-20-2020 22:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is
missing. Kindly
review and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae401e\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135660
Page 201 of 246
***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, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121112 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Dec-18-2020 18:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data E
…[truncated]