Document text
Page 1 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803888
Page 2 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/30/2020
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803889
Page 3 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11331006]
2.Birth Date: /1957
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803890
Page 4 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/30/2020
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803891
Page 5 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803892
Page 6 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803893
Page 7 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803894
Page 8 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803895
Page 9 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathJul/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803896
Page 10 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Open Heart Surgery]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colectomy Hartman]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Strock (CVA)]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803897
Page 11 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Prostate Hyperplasia]
Start Date: UNK/UNK/2012
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2008
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congestive Hearth Failure (CHF)]
Start Date: UNK/UNK/2012
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ischemic colitis]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803898
Page 12 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bipolar Disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Schizophrenia with paranoia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ETOH abuse]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803899
Page 13 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [112.0]
3.Unit: kg
4.Height: [179.0]
5.Unit: cm
6.Body Mass Index: [35.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803900
Page 14 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/31/2020
2.Randomization Number: [220755]
3.Randomization Group: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803901
Page 15 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNB4TW]
5.bSample ID [BNB4TX]
5.cSample ID [BNB4TY]
5.dSample ID [BPFS04]
5.eSample ID [BPFS05]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803902
Page 16 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNB52H]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803903
Page 17 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: Jul/31/2020 10:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803904
Page 18 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803905
Page 19 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803906
Page 20 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803907
Page 21 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803908
Page 22 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803909
Page 23 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BPY1S0]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803910
Page 24 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 11:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803911
Page 25 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803912
Page 26 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803913
Page 27 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803914
Page 28 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[The blood was unable to draw due to the subject was dehydrated.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803915
Page 29 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803916
Page 30 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803917
Page 31 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803918
Page 32 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803919
Page 33 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803920
Page 34 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803921
Page 35 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803922
Page 36 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803923
Page 37 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803924
Page 38 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803925
Page 39 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803926
Page 40 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803927
Page 41 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803928
Page 42 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803929
Page 43 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Worsening Bipolar Di
sorder Aug/24/2020 0
8:00 NO
End Date Time:
Sep/4/2020 14:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Urinary tract infectio
n Oct/5/2020 10:
00 NO
End Date Time:
Oct/14/2020 10:00
Repeating
Pages
3.ADVERSE EV
ENT 3 Syncope Oct/5/2020 10:
00 NO
End Date Time:
Oct/5/2020 10:00
Repeating
Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803930
Page 44 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Worsening Bipolar Disorder]
4.Start Date Time: Aug/24/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/4/2020 14:00
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
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803931
Page 45 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Psychiatric illness]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020336469]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803932
Page 46 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Urinary tract infection]
4.Start Date Time: Oct/5/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/14/2020 10:00
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
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803933
Page 47 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Escherichia coli]
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[2020387703]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803934
Page 48 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Syncope]
4.Start Date Time: Oct/5/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/5/2020 10:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Urinary tract Infection]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803935
Page 49 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803936
Page 50 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803937
Page 51 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803938
Page 52 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803939
Page 53 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803940
Page 54 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803941
Page 55 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803942
Page 56 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803943
Page 57 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803944
Page 58 of 254
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803945
Page 59 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803946
Page 60 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803947
Page 61 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803948
Page 62 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803949
Page 63 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803950
Page 64 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803951
Page 65 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803952
Page 66 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803953
Page 67 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803954
Page 68 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803955
Page 69 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803956
Page 70 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803957
Page 71 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803958
Page 72 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803959
Page 73 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803960
Page 74 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BR4ZMJ]
5.bSample ID [BSFD64]
5.cSample ID [BSFD65]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803961
Page 75 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BR4ZM7]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803962
Page 76 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/22/2021 10:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803963
Page 77 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803964
Page 78 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BRKJ99]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803965
Page 79 of 254
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/12/2021 09:47
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
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803966
Page 80 of 254
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803967
Page 81 of 254
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803968
Page 82 of 254
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803969
Page 83 of 254
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803970
Page 84 of 254
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803971
Page 85 of 254
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803972
Page 86 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803973
Page 87 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/5/2020
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803974
Page 88 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803975
Page 89 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 12:13:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803976
Page 90 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-22-2021 14:01:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803977
Page 91 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 12:13:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-29-2020 10:57:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Nov-04-2020 14:55:47 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-23-2020 08:09:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803978
Page 92 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Howard
Schwartz Approved Oct-22-2020 14:38:50 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-20-2020 14:49:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Oct-13-2020 22:07:16 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-13-2020 15:28:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Oct-13-2020 10:14:40 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803979
Page 93 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-05-2020 16:13:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Sep-23-2020 19:39:16 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-21-2020 13:28:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Sep-16-2020 14:50:31 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803980
Page 94 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-15-2020 16:29:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Sep-15-2020 14:29:58 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-02-2020 07:43:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-01-2020 15:42:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803981
Page 95 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803982
Page 96 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-31-2020 11:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-31-2020 11:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803983
Page 97 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-31-2020 11:37:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Jul/30/2020Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803984
Page 98 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 07:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed confirmed event
added in AE CRF
Sep-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data was updated
Sep-01-2020 07:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:AER#
2020336469
worsening
bipolar(onset
date:24Aug2020)was
reported as serious in
Safety database but
missing in AE CRF.
Please confirm and
update CRF. If safety
update is required,
submit a follow-up
SAE Form.
Jul-31-2020 11:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11331006Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-31-2020 11:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-31-2020 11:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803985
Page 99 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4. Ethnicity:
Date Location User Value Reason
Jul-31-2020 11:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-31-2020 11:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803986
Page 100 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-31-2020 11:38:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803987
Page 101 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Crite
rion
Descr
iption
:Male or female participa
nts between the ages of
18 and 55 years, inclusi
ve, 65 and 85 years, incl
usive, or 18 and 85 year
s, inclusive, at randomiz
ation (dependent upon st
udy stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants bet
ween the ages of 18 and 55 yearInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803988
Page 102 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
s, inclusive, 65 and 85 years, inc
lusive, or 18 and 85 years, inclu
sive, at randomization (depende
nt upon study stage)
1.a Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umber
:2
Criter
ion De
scripti
on:Participants who are wi
lling and able to compl
y with all scheduled vis
its, vaccination plan, la
boratory tests, lifestyle
considerations, and oth
er study procedures
Criter
ion m
et?:YESInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803989
Page 103 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and
able to comply with all schedule
d visits, vaccination plan, labora
tory tests, lifestyle consideration
s, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803990
Page 104 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:3
Criter
ion De
scripti
on:Healthy participants wh
o are determined by me
dical history, physical e
xamination, and clinical
judgment of the investi
gator to be eligible for i
nclusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803991
Page 105 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Inclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are det
ermined by medical history, phy
sical examination, and clinical j
udgment of the investigator to b
e eligible for inclusion in the stu
dyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion Nu
mber:4Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803992
Page 106 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion De
scripti
on:Capable of giving perso
nal signed informed co
nsent, which includes c
ompliance with the req
uirements and restrictio
ns listed in the ICD and
in this protocol
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803993
Page 107 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Inclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal sign
ed informed consent, which incl
udes compliance with the requir
ements and restrictions listed in
the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803994
Page 108 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion D
escrip
tion:Other medical or psychi
atric condition incl. rece
nt (within past year) or
active suicidal ideation/
behavior/lab abnormalit
y that may increase the
risk of study participati
on
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric con
dition incl. recent (within past y
ear) or active suicidal ideation/b
ehavior/lab abnormality that ma
y increase the risk of study parti
cipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803995
Page 109 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descr
iption:Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803996
Page 110 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.b Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human im
munodeficiency virus (HIV), he
patitis C virus (HCV), or hepatit
is B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803997
Page 111 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion De
scripti
on:History of severe adver
se reaction associated w
ith a vaccine and/or sev
ere allergic reaction (eg
, anaphylaxis) to any co
mponent of the study in
tervention(s)
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803998
Page 112 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.c Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reacti
on associated with a vaccine and
/or severe allergic reaction (eg, a
naphylaxis) to any component o
f the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to
prevent COVID-1
9Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0803999
Page 113 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu8Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804000
Page 114 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
mber:
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunode
ficiency, as determined
by history and/or labor
atory/physical examina
tion
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804001
Page 115 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.e Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individual
s with known or suspected imm
unodeficiency, as determined by
history and/or laboratory/physic
al examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804002
Page 116 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding th
at would, in the opinion
of the investigator, cont
raindicate intramuscula
r injection
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804003
Page 117 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.f Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition
associated with prolonged bleedi
ng that would, in the opinion of
the investigator, contraindicate i
ntramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeedingInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804004
Page 118 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or bre
astfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:12Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804005
Page 119 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccine
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any c
oronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-31-2020 11:38:43 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804006
Page 120 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemi
c corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX13A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804007
Page 121 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.i Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosu
ppressive therapy, such as cytoto
xic agents or systemic corticoste
roidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804008
Page 122 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criteri
on Des
criptio
n:Receipt of blood/plasm
a products or immunog
lobulin, from 60 days b
efore study intervention
administration or plann
ed receipt throughout t
he study
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804009
Page 123 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.j Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma product
s or immunoglobulin, from 60 d
ays before study intervention ad
ministration or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804010
Page 124 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
2.k
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other s
tudies involving study
intervention within 28
days prior to study ent
ry and/or during study
participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX15A01Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804011
Page 125 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.k Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies in
volving study intervention withi
n 28 days prior to study entry an
d/or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804012
Page 126 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX16A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804013
Page 127 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.l Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other s
tudies involving study interventi
on containing lipid nanoparticle
sInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804014
Page 128 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees direct
ly involved in the cond
uct of the study, site staf
f otherwise supervised
by the investigator, and
their respective family
members
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804015
Page 129 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.m Exclusion Number:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in th
e conduct of the study, site staff
otherwise supervised by the inv
estigator, and their respective fa
mily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 11:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804016
Page 130 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-31-2020 11:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-31-2020 11:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-31-2020 11:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804017
Page 131 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 11:49:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Coronary Artery
Disease
Start Date: UNK/UNK/200
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-31-2020 11:49:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 14:22:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-15-2020 12:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Medical history was
updated
Sep-14-2020 07:22:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Med Hx of subject
has been updated in
SDB, recording:
(CABG)in 2009
and in 2013, CHF
from 2012 and
ongoing, CVA in
2014, among other
items. Please
revise/update
accordingly.
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804018
Page 132 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jul-31-2020 11:49:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary Artery DiseaseInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-31-2020 11:49:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-31-2020 11:49:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-15-2020 12:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Open Heart S
urgery
Start Date: UNK/UNK/20
09
Ongoing: NO
End Date:
UNK/UNK
/2009Transcription Error
Sep-15-2020 12:29:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Open Heart S
urgery
Start Date: UNK/UNK/20
08Transcription Error
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804019
Page 133 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK
/2009
Jul-31-2020 11:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Open Heart S
urgery
Start Date: UNK/UNK/20
09
Ongoing: NO
End Date:
UNK/UNK
/2009Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804020
Page 134 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Jul-31-2020 11:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 11:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Open Heart SurgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-15-2020 12:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Transcription Error
Sep-15-2020 12:29:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Transcription Error
Jul-31-2020 11:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-31-2020 11:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.c
Date Location User Value Reason
Sep-16-2020 14:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num 3Transcription Error
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804021
Page 135 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
ber:
Medical Histor
y Term:Colectomy Ha
rtman
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017
Sep-15-2020 16:30:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Colectomy Hart
man/Ileostomy
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/20
17Transcription Error
Sep-15-2020 16:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Colectomy Hart
man/Ileostomy
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/19
66Transcription Error
Sep-15-2020 12:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Colectomy Hart
man/Ileostomy
Start Date: UNK/UNK/1966Transcription Error
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804022
Page 136 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/19
66
Aug-11-2020 07:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Karla Pentzke Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Endo cholecyst
ectomy
Start Date: UNK/UNK/19
66
Ongoing: NO
End Date:
UNK/UNK/
1966Transcription Error
Aug-10-2020 14:16:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Karla Pentzke Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Endo colstect
omy
Start Date: UNK/UNK/19
66
Ongoing: NO
End Date:
UNK/UNK
/1966spelling
Aug-05-2020 11:30:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Enterocolosto
my
Start Date: UNK/UNK/19
66
Ongoing: NO
End Date:
UNK/UNK
/1966Changed
Information
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804023
Page 137 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jul-31-2020 11:57:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:end colostomy
Start Date: UNK/UNK/19
66
Ongoing: NO
End Date:
UNK/UNK
/1966Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804024
Page 138 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Jul-31-2020 11:57:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-16-2020
18:04:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
5: Clo
sedDiscrepancy has been
closed.
Sep-16-2020
14:35:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
5: An
swere
dTranscription Error
Sep-16-2020
14:35:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Colect
omy
Hartm
anTranscription Error
Sep-16-2020
10:18:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason
GongQuery
4: Clo
sedResponse satisfies query
Sep-16-2020
01:58:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
5: Op
enedMultiple concepts in the
term COLECTOMY
HARTMAN/ILEOSTOMY.
Split the term into
COLECTOMY
HARTMAN and
ILEOSTOMY and report
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804025
Page 139 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
as 2 separate entries. Thank
you.
Sep-15-2020
16:30:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
4: An
swere
dChanged data per query
Sep-15-2020
12:50:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason
GongQuery
4: Op
enedGPDClin: 1) The
participant has a MHx of
ischemic colitis 2017, was
this procedure performed
for that? If yes, please
correct the time to 2017. 2)
the initial entry was "endo
cholecystectomy" 1966,
should "cholecystectomy"
1966 a separate MHx item?
Sep-15-2020
12:41:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason
GongQuery
3: Clo
sedResponse satisfies query
Sep-15-2020
12:37:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: An
swere
dTranscription Error
Sep-15-2020
12:37:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Colect
omy
Hartm
an/Ile
ostom
yTranscription Error
Sep-14-2020
15:52:43
(UTC-05:00)ACV0PFEINFP6000 Quan Jason
GongQuery
3: Op
enedGPDClin: 1) Please add the
missing psychiatric MHx:
bipolar affective disorder,
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804026
Page 140 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US &
Canada)paranoid schizophrenia; or,
Schizoaffective disorder,
etc. 2) Based on the
missing MHx, please
re-assess eligibility against
Inclusion #3 and Exclusion
#1.
Aug-11-2020
19:39:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
2: Clo
sedDiscrepancy has been
closed.
Aug-11-2020
10:19:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason
GongQuery
2: Rei
ssued:
Opene
dPlease confirm it was
"cholecystectomy" without
"endo" as Laparoscopic
cholecystectomy was not
available in 1966 when this
procedure was performed.
Aug-11-2020
07:29:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dTranscription Error
Aug-11-2020
07:29:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Data
Entry
:
Endo
cholec
ystect
omyTranscription Error
Aug-11-2020
04:16:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Aug-10-2020
18:15:32
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
2: Op
enedClarify ENDO
COLSTECTOMY as
follows...Term is unclear.
Are you reporting ENDO
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804027
Page 141 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US &
Canada)CHOLECYSTECTOMY?
Or COSTECTOMY? Or
other? Please update the
verbatim term to clarify.
Thank you.
Aug-10-2020
14:16:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dspelling
Aug-10-2020
14:16:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Data
Entry
:
Endo
colste
ctomyspelling
Aug-10-2020
08:59:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Luke Cunliffe Query
1: Rei
ssued:
Opene
dPlease specify what
information has changed.
Thank you.
Aug-05-2020
11:30:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Aug-05-2020
11:30:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Enter
ocolos
tomyChanged Information
Aug-03-2020
17:13:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Luke Cunliffe Query
1: Op
enedClinical review: Per CRF
completion requirements
(8.6), when a surgery or
interventional procedure is
recorded, the condition that
led to the
surgery/procedure MUST
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804028
Page 142 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
be recorded as a separate
entry. Please evaluate and
take appropriate action.
Jul-31-2020
11:57:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
end c
olosto
myInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804029
Page 143 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.c Start Date:
Date Location User Value Reason
Sep-15-2020 16:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Transcription Error
Jul-31-2020 11:57:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-15-2020 16:30:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-15-2020 16:30:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Transcription Error
Sep-15-2020 16:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Term Colectomy
Hartman/Ileostomy
End Date is prior to
Start Date.
Jul-31-2020 11:57:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1966Initial Entry
1.d
Date Location User Value Reason
Sep-15-2020 12:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Strock (CVA)Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804030
Page 144 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/20
14
Ongoing: NO
End Date:
UNK/UNK/
2014
1.d Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Strock (CVA)Initial Entry
1.d Start Date:
Date Location User Value Reason
Sep-15-2020 12:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-15-2020 12:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.e
Date Location User Value Reason
Sep-15-2020 12:26:25 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804031
Page 145 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Num
ber:5
Medical Histo
ry Term:Benign Prostate
Hyperplasia
Start Date: UNK/UNK/2012
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Benign Prostate HyperplasiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-15-2020 12:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-15-2020 12:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-15-2020 12:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804032
Page 146 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
008
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-15-2020 12:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-15-2020 12:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-15-2020 12:28:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Hyperlipidem
iaInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804033
Page 147 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/2
008
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:28:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:28:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-15-2020 12:28:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-15-2020 12:28:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-15-2020 12:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Congestive Hearth
Failure (CHF)
Start Date: UNK/UNK/2012Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804034
Page 148 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Congestive Hearth Failure (CHF
)Initial Entry
1.h Start Date:
Date Location User Value Reason
Sep-15-2020 12:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-15-2020 12:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-15-2020 12:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Ischemic colitis
Start Date: UNK/UNK/20
17Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804035
Page 149 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/
2017
1.i Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ischemic colitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-15-2020 12:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-15-2020 12:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.j
Date Location User Value Reason
Sep-15-2020 16:31:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:10Transcription Error
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804036
Page 150 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical History
Term:Bipolar Diso
rder
Start Date: UNK/UNK/
2018
Ongoing: YES
Sep-15-2020 12:31:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:Bipolar
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804037
Page 151 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.j Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:31:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
17:37:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Clos
edResponse
satisfies query
Sep-16-2020
15:56:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
weredThis symptoms
ocurred for the
first time on
24Aug2020
Sep-16-2020
10:25:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Reis
sued:OpenedGPDClin: please
address my
query that if any
suicide attempts
and/or ideations
occurred in the
past? If yes,
please add it as a
separate MHx
item.
Sep-16-2020
05:52:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Clos
edDiscrepancy has
been closed.
Sep-15-2020
16:31:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ans
weredTranscription
Error
Sep-15-2020 ACV0PFEINFP6000 auto query Query 1: Ans Transcription
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804038
Page 152 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
16:31:32
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) wered Error
Sep-15-2020
16:31:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bipolar Disor
derTranscription
Error
Sep-15-2020
15:06:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Ope
nedClarify
BIPOLAR as
follows...The
term appears
truncated. Are
you reporting
BIPOLAR
DISORDER?
BIPOLAR
PACEMAKER
INSERTION? If
so, edit.
Otherwise
clarify. Thank
you.
Sep-15-2020
13:33:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Ope
nedGPDClin:
Please clarify if
any suicide
attempts and/or
ideations
occurred in the
past. If yes,
please add it as a
separate MHx
item.
Sep-15-2020
12:31:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BipolarInitial Entry
1.j Start Date:
Date Location User Value Reason
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804039
Page 153 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-15-2020 12:31:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804040
Page 154 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.j Ongoing:
Date Location User Value Reason
Sep-15-2020 12:31:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-15-2020 12:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:Schizophrenia wi
th paranoia
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804041
Page 155 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 17:37:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-16-2020 14:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject stable. Able
to continue in the
study. Aprroved by
PI.
Sep-16-2020 10:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Thank
you! I understand
that those are
missing MHx not
reported by the
participant at
enrollment. My
question is that
retrospectively, if PI
knew those at
enrollment, would
he consider the
subject eligible
based on (In#3 and
Ex#1).
Sep-15-2020 16:33:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This data came with
the medical record
that was requested
due to the SAE.
Sep-15-2020 13:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: As those
unreported MHx
(Bipolar,
Schizophrenia,
alcohol abuse)
became available,
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804042
Page 156 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
along with other
MHx in GI and CV,
please provide PI's
retrospective
assessment on
eligibility,
particularly against
Inclusion#3 and
Ex#1.
Sep-15-2020 12:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Schizophrenia with paranoiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-15-2020 12:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-15-2020 12:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-15-2020 12:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:ETOH abuse
Start Date: UNK/UNK/20
00
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804043
Page 157 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ETOH abuseInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-15-2020 12:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-15-2020 12:35:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804044
Page 158 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
112.0Initial Entry
3. Unit:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
179.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.0Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804045
Page 159 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7.a
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.2
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-31-2020 11:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804046
Page 160 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-31-2020 11:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-31-2020 11:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
220755Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804047
Page 161 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 11:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 11:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 15:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 07:38:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jul-31-2020 11:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jul-31-2020 11:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/31/2020Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804048
Page 162 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Aug-05-2020 15:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4TWInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 15:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4TWInitial Entry
5.b
Date Location User Value Reason
Aug-05-2020 15:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4TXInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 15:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4TXInitial Entry
5.c
Date Location User Value Reason
Aug-05-2020 15:52:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4TYInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 15:52:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4TYInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804049
Page 163 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d
Date Location User Value Reason
Aug-05-2020 15:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFS04Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 15:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPFS04Initial Entry
5.e
Date Location User Value Reason
Aug-05-2020 15:58:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFS05Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 15:58:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPFS05Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804050
Page 164 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 11:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 11:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-01-2020 12:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-31-2020 11:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jul-31-2020 11:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-01-2020 12:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB52HInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804051
Page 165 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-01-2020 12:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB52HInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804052
Page 166 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020 04:30:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Aug-10-2020 14:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Karla Pentzke Query 1: Answered Changed data per
query
Aug-10-2020 09:30:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Requery #3:
Thank you for
response. Please
consider to update
item level comment
to specify the
reason for 1 day
delay. As the
"appointment is not
qualified as a
temporary delay of
vaccination (refer
protocol section
5.5. Else clarify.
Aug-07-2020 13:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered There is no option
available for delay,
options available do
not apply.
Aug-06-2020 07:29:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Requery # 2:
Thanks for updating
the response for
delay of vaccination
however form or
item level comment
for reason for 1 day
delay is still not
reported on
eCRF.Please
consider to record
form or item level
comment for reason
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804053
Page 167 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
for delay.
Aug-05-2020 15:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Aug-05-2020 15:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOChanged
Information
Aug-05-2020 05:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Review: Please
response to “Was
there a temporary
delay of
vaccination?' is
marked as “No” and
update the reason
for 1 day delay in a
form or item level.
As "appointment is
not qualified as a
temporary delay of
vaccination (refer
protocol section
5.5.
Jul-31-2020 11:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject was unable
to complete visit on
07/30/2020, due to
an appointment.
Approval from
sponsor to give
vaccination to
subject on
07/31/2020.
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Was there a
temporary delay of
vaccination?' is
marked as Yes and
'Reason(s) for
Temporary Delay of
Vaccination' is not
entered. Please
review and update
as appropriate.
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804054
Page 168 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Jul/30/2020Initial Entry
2. Treatment Name
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Aug-18-2020
21:26:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Aug-14-2020
09:39:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredVISIT WAS SPLIT
BETWEEN JUL 30
AND JUL 31.
CONSENT
SIGNED ON JULY
30TH AND
RANDOMIZED
ON THE 31ST.
Aug-13-2020
19:24:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ope
nedTemperature
collected date on
vital signs CRF and
vaccination date are
different. Please
review dates and
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804055
Page 169 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
update as
appropriate or
otherwise clarify.
Aug-12-2020
09:12:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedPer site confirmation
Aug-12-2020
08:40:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Aug-12-2020
08:40:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jul/31/
2020 1
0:08Transcription Error
Aug-11-2020
11:42:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW4173108;Dose
Start Date is before
the Randomization
Date. Please review
and update as
appropriate.
Aug-10-2020
14:23:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Data
Entry
:
Jul/30/
2020 1
0:08Transcription Error
Jul-31-2020
11:43:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jul/31/
2020 1
0:08Initial Entry
5. Anatomical Location:
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804056
Page 170 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jul-31-2020 11:43:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804057
Page 171 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-10-2020 06:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Aug-07-2020 09:03:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Aug-07-2020 09:03:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTChanged
Information
Aug-07-2020 01:47:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: Patient
is expected to be
included in the
Reactogenicity
subset. Please
review and update
as appropriate
Jul-31-2020 11:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804058
Page 172 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020 11:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804059
Page 173 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804060
Page 174 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804061
Page 175 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.c Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804062
Page 176 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804063
Page 177 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.f Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804064
Page 178 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-21-2020 11:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804065
Page 179 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804066
Page 180 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-21-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804067
Page 181 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2.a
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.0
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804068
Page 182 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804069
Page 183 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 11:50:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 11:50:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 09:06:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 11:50:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-21-2020 11:50:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-22-2020 09:06:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY1S0Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804070
Page 184 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 09:06:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY1S0Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804071
Page 185 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020 11:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804072
Page 186 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-21-2020 11:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804073
Page 187 of 254
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 07:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation -
updated PD tracker
Oct-06-2020 12:55:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject came out of
window due to a
scheduled ileostomy
reversal surgery. A
protocol deviation
was performed.
Oct-06-2020 07:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: DOV at this
visit is out of
window (10 day)
from DOV (21/Aug
/2020) at
V2_VAX2_L.
Please reconcile and
update accordingly,
else confirm date is
correct as is.
Oct-05-2020 16:13:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804074
Page 188 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804075
Page 189 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804076
Page 190 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804077
Page 191 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804078
Page 192 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.f Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ef7\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804079
Page 193 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h
Date Location User Value Reason
Oct-05-2020 16:15:38
(UTC-05:00) Eastern
Time (US & Canada
…[truncated]