Document text
Page 1 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981462
Page 2 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/30/2020
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981463
Page 3 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11271023]
2.Birth Date: /1949
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981464
Page 4 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/30/2020
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981465
Page 5 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981466
Page 6 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981467
Page 7 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981468
Page 8 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981469
Page 9 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Non-Steroidal Anti-Inflammatory drugs]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1960
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1962
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hearing Loss Bilateral]
Start Date: UNK/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981470
Page 10 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/1998
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1995
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bronchitis - Recurrent]
Start Date: UNK/UNK/1960
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/1992
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[postmenopausal]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981471
Page 11 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[urinary Tract Infection - Recurrent]
Start Date: UNK/UNK/1951
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis - Generalized]
Start Date: UNK/UNK/2008
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis - Bilateral Hips]
Start Date: UNK/UNK/2008
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis - Left Shoulder]
Start Date: UNK/UNK/2018
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981472
Page 12 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/1995
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine polyps]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981473
Page 13 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [77.1]
3.Unit: kg
4.Height: [157.0]
5.Unit: cm
6.Body Mass Index: [31.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981474
Page 14 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981475
Page 15 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/30/2020
2.Randomization Number: [220724]
3.Randomization Group: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981476
Page 16 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPL2ZT]
5.bSample ID [BPL2ZS]
5.cSample ID [BP3RL8]
5.dSample ID [BP3RL9]
5.eSample ID [BP3RLB]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981477
Page 17 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3RL7]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981478
Page 18 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/30/2020 17:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981479
Page 19 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981480
Page 20 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981481
Page 21 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?YES
Ongoing?
NO
Stop Date:
Aug/6/2020
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?YES
Ongoing?
NO
Stop Date:
Aug/6/2020
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
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981482
Page 22 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981483
Page 23 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981484
Page 24 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981485
Page 25 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BP3RX5]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981486
Page 26 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/18/2020 10:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981487
Page 27 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981488
Page 28 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981489
Page 29 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981490
Page 30 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3S4R]
5.bSample ID [BP3S4S]
5.cSample ID [BP3S4T]
5.dSample ID [BPL366]
5.eSample ID [BPL365]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981491
Page 31 of 279
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981492
Page 32 of 279
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/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 [BPL4MS]
5.bSample ID [BPL4MN]
5.cSample ID [BP9VW5]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981493
Page 33 of 279
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981494
Page 34 of 279
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981495
Page 35 of 279
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981496
Page 36 of 279
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981497
Page 37 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981498
Page 38 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/11/2020
2.Date of First Symptom Started: Nov/8/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981499
Page 39 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981500
Page 40 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981501
Page 41 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981502
Page 42 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[not applicable]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981503
Page 43 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9VN4]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981504
Page 44 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981505
Page 45 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981506
Page 46 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981507
Page 47 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981508
Page 48 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981509
Page 49 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981510
Page 50 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981511
Page 51 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981512
Page 52 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981513
Page 53 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981514
Page 54 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981515
Page 55 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981516
Page 56 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981517
Page 57 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981518
Page 58 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981519
Page 59 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981520
Page 60 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981521
Page 61 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981522
Page 62 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981523
Page 63 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981524
Page 64 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981525
Page 65 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/9/2020
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 [BP9VP0]
5.bSample ID [BPL4HJ]
5.cSample ID [BPL4HK]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981526
Page 66 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981527
Page 67 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981528
Page 68 of 279
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981529
Page 69 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981530
Page 70 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981531
Page 71 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981532
Page 72 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 worsening of asthma Oct/1/2020 UN
K:UNK YES Repeating
Pages
2.ADVERSE E
VENT 2 Malignant invasive ductal carci
noma left breast Nov/5/2020 11:
55 YES Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981533
Page 73 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 of asthma]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
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:
[allergy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981534
Page 74 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981535
Page 75 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Malignant invasive ductal carcinoma left breast]
4.Start Date Time: Nov/5/2020 11:55
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[malignancy]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981536
Page 76 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020453457]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981537
Page 77 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981538
Page 78 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981539
Page 79 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Influenza vaccin
ation Sep/8/20
20 Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981540
Page 80 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influenza vaccination]
5.Date: Sep/8/2020
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981541
Page 81 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981542
Page 82 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981543
Page 83 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981544
Page 84 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981545
Page 85 of 279
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981546
Page 86 of 279
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981547
Page 87 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981548
Page 88 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981549
Page 89 of 279
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981550
Page 90 of 279
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981551
Page 91 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981552
Page 92 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981553
Page 93 of 279
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981554
Page 94 of 279
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981555
Page 95 of 279
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981556
Page 96 of 279
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981557
Page 97 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981558
Page 98 of 279
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981559
Page 99 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981560
Page 100 of 279
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981561
Page 101 of 279
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981562
Page 102 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/15/2020
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981563
Page 103 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981564
Page 104 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tracy Klein Approved Mar-09-2021 08:43:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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.
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981565
Page 105 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981566
Page 106 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Jul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981567
Page 107 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Jul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981568
Page 108 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Jul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981569
Page 109 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Jul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981570
Page 110 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Jul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada) )Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981571
Page 111 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aJul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981572
Page 112 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aJul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981573
Page 113 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aJul-31-2020 08:38:15 (UTC-06:00) Central Time
(US & Canada)Female Non-child Bearing Potential
Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981574
Page 114 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981575
Page 115 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Aug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981576
Page 116 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Aug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981577
Page 117 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Aug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981578
Page 118 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Aug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981579
Page 119 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Aug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981580
Page 120 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aAug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981581
Page 121 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aAug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981582
Page 122 of 279
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aAug-18-2020 14:31:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981583
Page 123 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormNov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981584
Page 124 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981585
Page 125 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981586
Page 126 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981587
Page 127 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981588
Page 128 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981589
Page 129 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981590
Page 130 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
7Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981591
Page 131 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
8Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981592
Page 132 of 279
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
9Nov-11-2020 16:16:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981593
Page 133 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tracy Klein Approved Mar-09-2021 08:43:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-22-2021 16:17:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein Approved Jan-26-2021 12:27:39 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-22-2021 16:29:36 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein Approved Jan-21-2021 11:46:21 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981594
Page 134 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, TracyKlein, 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-09-2020 11:40:11 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Terry Klein Approved Nov-17-2020 16:24:17 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TerryKlein, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-11-2020 16:06:10 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein Approved Oct-12-2020 16:45:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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.
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981595
Page 135 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
N/A Oct-06-2020 08:29:05 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein Approved Sep-16-2020 12:00:54 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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 15:11:11 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein Approved Sep-15-2020 08:33:03 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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.
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981596
Page 136 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-31-2020 08:11:56
(UTC-06:00) Central 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 08:11:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981597
Page 137 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-31-2020 08:12:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981598
Page 138 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-31-2020 08:11:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11271023Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-31-2020 08:11:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-31-2020 08:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-31-2020 08:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-31-2020 08:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981599
Page 139 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-31-2020 08:12:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981600
Page 140 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizat
ion (dependent upon study stage)Initial Entry
1.a Criterion met?
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981601
Page 141 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests,
lifestyle considerations, an
d other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981602
Page 142 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Inclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and abl
e to comply with all scheduled visits
, vaccination plan, laboratory tests, l
ifestyle considerations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical h
istory, physical examinatio
n, and clinical judgment of
the investigator to be eligib
le for inclusion in the studyInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981603
Page 143 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are determ
ined by medical history, physical ex
amination, and clinical judgment of
the investigator to be eligible for inc
lusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981604
Page 144 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes compliance
with the requirements and
restrictions listed in the IC
D and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981605
Page 145 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Inclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981606
Page 146 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increa
se the risk of study particip
ation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or
active suicidal ideation/behavior/lab
abnormality that may increase the ri
sk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981607
Page 147 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vi
rus (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981608
Page 148 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.b Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human immu
nodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allerg
ic reaction (eg, anaphylaxi
s) to any component of the
study intervention(s)Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981609
Page 149 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or sever
e allergic reaction (eg, anaphylaxis)
to any component of the study interv
ention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981610
Page 150 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981611
Page 151 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical e
xamination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981612
Page 152 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals w
ith known or suspected immunodefi
ciency, as determined by history and
/or laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the invest
igator, contraindicate intra
muscular injectionInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981613
Page 153 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition asso
ciated with prolonged bleeding that
would, in the opinion of the investig
ator, contraindicate intramuscular inj
ectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981614
Page 154 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastf
eedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981615
Page 155 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981616
Page 156 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic agen
ts or systemic corticoster
oids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01Initial Entry
2.i Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agen
ts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981617
Page 157 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.j
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study
intervention administration
or planned receipt through
out the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX14A01Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981618
Page 158 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.j Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befo
re study intervention administration
or planned receipt throughout the stu
dyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981619
Page 159 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
2.k
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981620
Page 160 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.k Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies involvi
ng study intervention within 28 day
s prior to study entry and/or during
study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention con
taining lipid nanoparticl
es
Criterion
met?:NOInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981621
Page 161 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other studi
es involving study intervention cont
aining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981622
Page 162 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly inv
olved in the conduct of the
study, site staff otherwise s
upervised by the investigat
or, and their respective fam
ily members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981623
Page 163 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.m Exclusion Number:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 08:14:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981624
Page 164 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-31-2020 08:16:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-31-2020 08:16:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-31-2020 08:16:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981625
Page 165 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 15:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:1
Medical
History T
erm:Allergy to Non-Ste
roidal Anti-Inflam
matory drugs
Start Dat
e:UNK/UNK/1990
Ongoing: YESTranscription Error
Jul-31-2020 08:18:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:Non-Steroidal Anti-
Inflammatory - Wh
eezing/Coughing
Start Da
te:UNK/UNK/1990
Ongoing
:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:18:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Jul-31-2020
16:50:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Clo
sedDiscrepancy has been
closed.
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981626
Page 166 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020
15:57:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Jul-31-2020
15:57:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Allerg
y to N
on-Ste
roidal
Anti-I
nflam
mator
y drug
sTranscription Error
Jul-31-2020
13:47:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedClarify
NON-STEROIDAL
ANTI-INFLAMMATORY
-
WHEEZING/COUGHING
as follows...The term is
unclear. If reporting DRUG
INDUCED WHEEZING
and DRUG INDUCED
COUGHING, split into 2
separate entries as outlined.
If reporting
NON-STEROIDAL
ANTI-INFLAMMATORY
TREATMENT of
WHEEZING and
COUGHING, split into 3
separate entries as outlined
and also move the
NON-STEROIDAL
ANTI-INFLAMMATORY
to drug page and also
specify further the trade
name and/or active
ingredient(s). If reporting
ALLERGY TO
NON-STEROIDAL
ANTI-INFLAMMATORY
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981627
Page 167 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
-
WHEEZING/COUGHING,
split into ALLERGY TO
NON-STEROIDAL
ANTI-INFLAMMATORY
and WHEEZING and
ALLEWRGIC COUGH
and report as 3 separate
entries. Otherwise clarify
and update the verbatim
term as appropriate. Thank
you.
Jul-31-2020
08:18:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Non-S
teroid
al Ant
i-Infla
mmat
ory -
Whee
zing/
Coug
hingInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-31-2020 08:18:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-31-2020 08:18:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jul-31-2020 08:19:12
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 2Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981628
Page 168 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US & Canada) :
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/19
60
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:19:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:19:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-31-2020 08:19:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1960Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-31-2020 08:19:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jul-31-2020 08:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:MyopiaInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0981629
Page 169 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: UNK/UNK/1
962
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-31-2020 08:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1962Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-31-2020 08:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-31-2020 08:21:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Hearing Loss Bi
lateral
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981630
Page 170 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:21:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:21:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hearing Loss BilateralInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-31-2020 08:21:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-31-2020 08:21:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-31-2020 08:22:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Hypertension
Start Date: UNK/UNK/1
993
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981631
Page 171 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:22:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:22:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-31-2020 08:22:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1993Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-31-2020 08:22:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Jul-31-2020 08:23:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Hyperlipidemi
a
Start Date: UNK/UNK/1
998
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981632
Page 172 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:23:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:23:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Jul-31-2020 08:23:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jul-31-2020 08:23:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Jul-31-2020 08:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:Asthma
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981633
Page 173 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.g Start Date:
Date Location User Value Reason
Jul-31-2020 08:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.g Ongoing:
Date Location User Value Reason
Jul-31-2020 08:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Jul-31-2020 08:24:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Bronchitis - Rec
urrent
Start Date: UNK/UNK/196
0
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0981634
Page 174 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:24:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:24:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bronchitis - RecurrentInitial Entry
1.h Start Date:
Date Location User Value Reason
Jul-31-2020 08:24:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1960Initial Entry
1.h Ongoing:
Date Location User Value Reason
Jul-31-2020 08:24:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Jul-31-2020 08:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:hypothyroidis
m
Start Date: UNK/UNK/1
992
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981635
Page 175 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.i Start Date:
Date Location User Value Reason
Jul-31-2020 08:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.i Ongoing:
Date Location User Value Reason
Jul-31-2020 08:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981636
Page 176 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.j
Date Location User Value Reason
Jul-31-2020 08:27:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:postmenopaus
al
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:27:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:27:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
postmenopausalInitial Entry
1.j Start Date:
Date Location User Value Reason
Jul-31-2020 08:27:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.j Ongoing:
Date Location User Value Reason
Jul-31-2020 08:27:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981637
Page 177 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:28:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:urinary Tract Infecti
on - Recurrent
Start Date: UNK/UNK/1951
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:28:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:28:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
urinary Tract Infection - RecurrentInitial Entry
1.k Start Date:
Date Location User Value Reason
Jul-31-2020 08:28:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1951Initial Entry
1.k Ongoing:
Date Location User Value Reason
Jul-31-2020 08:28:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Jul-31-2020 08:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981638
Page 178 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Histor
y Term:osteoarthritis - Ge
neralized
Start Date: UNK/UNK/2008
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritis - GeneralizedInitial Entry
1.l Start Date:
Date Location User Value Reason
Jul-31-2020 08:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.l Ongoing:
Date Location User Value Reason
Jul-31-2020 08:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Jul-31-2020 08:30:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:osteoarthritis - Bil
ateral Hips
Start Date: UNK/UNK/2008Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981639
Page 179 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:30:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:30:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritis - Bilateral HipsInitial Entry
1.m Start Date:
Date Location User Value Reason
Jul-31-2020 08:30:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.m Ongoing:
Date Location User Value Reason
Jul-31-2020 08:30:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Jul-31-2020 08:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Osteoarthritis - Le
ft Shoulder
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981640
Page 180 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis - Left ShoulderInitial Entry
1.n Start Date:
Date Location User Value Reason
Jul-31-2020 08:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.n Ongoing:
Date Location User Value Reason
Jul-31-2020 08:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Jul-31-2020 08:31:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Te
rm:Migraines
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981641
Page 181 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:31:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:31:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MigrainesInitial Entry
1.o Start Date:
Date Location User Value Reason
Jul-31-2020 08:31:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.o Ongoing:
Date Location User Value Reason
Jul-31-2020 08:31:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Jul-31-2020 08:32:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Te
rm:Insomnia
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981642
Page 182 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:32:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 08:32:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.p Start Date:
Date Location User Value Reason
Jul-31-2020 08:32:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.p Ongoing:
Date Location User Value Reason
Jul-31-2020 08:32:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Jul-31-2020 16:00:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:17
Medical Histo
ry Term:Hysterectomy
Start Date: UNK/UNK/2
005
Ongoing: NO
End Date:
UNK/UN
K/2005Transcription Error
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981643
Page 183 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 08:33:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:17
Medical Hi
story Term:Hysterectomy -
Uterine Polyps
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2
005Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981644
Page 184 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Jul-31-2020 08:33:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020
16:50:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy has
been closed.
Jul-31-2020
16:00:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription Error
Jul-31-2020
16:00:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Hysterecto
myTranscription Error
Jul-31-2020
13:47:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
OpenedMultiple concepts in
the term
HYSTERECTOMY
- UTERINE
POLYPS. Split the
term into
HYSTERECTOMY
and UTERINE
POLYPS and report
as 2 separate
entries. Thank you.
Jul-31-2020
08:33:38
(UTC-06:00)
Central TimeACV0PFEINFP6000 Data Entr
y:
Hysterecto
my - UteriInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981645
Page 185 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US &
Canada)ne Polyps
1.q Start Date:
Date Location User Value Reason
Jul-31-2020 08:33:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.q Ongoing:
Date Location User Value Reason
Jul-31-2020 08:33:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.r
Date Location User Value Reason
Jul-31-2020 16:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:18
Medical History
Term:Uterine polyps
Start Date: UNK/UNK/200
2
Ongoing: NO
End Date:
UNK/UNK/
2005Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981646
Page 186 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.r Line/MH Number:
Date Location User Value Reason
Jul-31-2020 16:01:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 16:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Uterine polypsInitial Entry
1.r Start Date:
Date Location User Value Reason
Jul-31-2020 16:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.r Ongoing:
Date Location User Value Reason
Jul-31-2020 16:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981647
Page 187 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
77.1Initial Entry
3. Unit:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
157.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.3Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0981648
Page 188 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.a
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-31-2020 08:36:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981649
Page 189 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ide Not ApplicInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981650
Page 190 of 279
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US & Canada) ntifier: able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jul-31-2020 08:38:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981651
Page 191 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-31-2020 08:38:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-31-2020 08:38:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
220724Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981652
Page 192 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 08:47:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 08:47:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-31-2020 08:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-31-2020 08:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-31-2020 08:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-31-2020 08:49:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL2ZTInitial Entry
5.a Sample ID
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981653
Page 193 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-31-2020 08:49:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2ZTInitial Entry
5.b
Date Location User Value Reason
Jul-31-2020 08:49:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL2ZSInitial Entry
5.b Sample ID
Date Location User Value Reason
Jul-31-2020 08:49:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2ZSInitial Entry
5.c
Date Location User Value Reason
Jul-31-2020 08:50:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3RL8Transcription Error
Jul-31-2020 08:50:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3RL89Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981654
Page 194 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Jul-31-2020 08:50:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jul-31-2020 08:50:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3RL8Transcription Error
Jul-31-2020 08:50:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Jul-31-2020 08:50:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3RL89Initial Entry
5.d
Date Location User Value Reason
Jul-31-2020 08:50:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3RL9Initial Entry
5.d Sample ID
Date Location User Value Reason
Jul-31-2020 08:50:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3RL9Initial Entry
5.e
Date Location User Value Reason
Jul-31-2020 08:51:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3RLBInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981655
Page 195 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.e Sample ID
Date Location User Value Reason
Jul-31-2020 08:51:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3RLBInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0981656
Page 196 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 08:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 08:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-31-2020 08:52:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-31-2020 08:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-31-2020 08:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-31-2020 08:52:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3RL7Initial Entry
5.a Sample ID
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981657
Page 197 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-31-2020 08:52:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3RL7Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0981658
Page 198 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020 17:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981659
Page 199 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7. Route:
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-31-2020 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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 08:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981660
Page 200 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jul-31-2020 08:46:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981661
Page 201 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 01:49:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-26-2020 08:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered page completed
Aug-25-2020 02:53:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query:
Vaccination
symptoms diary left
blank. Please
review and update
the vaccination
symptoms diary.
Thank you.
Aug-18-2020 14:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981662
Page 202 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-12-2020 05:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-11-2020 13:28:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-11-2020 13:28:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/6/2020New Information
Sep-02-2020 05:10:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened eDiary RQ1: Per
eDiary records, last
day of the eDiary
completed is
05-Aug-2020 which
is Day 7
FEVER/PAIN MED
is reported however
here it is recorded as
No. Please verify
and update. Else,
clarify. Thanks.
Sep-01-2020 08:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject did not take
medication on the
last day of diary.
Subject took
medication on
08/01/2020 for
headache and it is
capture on Conmed
log
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981663
Page 203 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-27-2020 09:50:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened e-Diary: Per eDiary
records,
FEVER/PAIN MED
is reported on Last
day (Day 7)
however the last day
in inform is entered
as 'No' for the same.
Please verify and
update. Else, clarify.
Thanks.
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0981664
Page 204 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000
)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-26-2020 09:24:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEADA
CHE
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:YES
Ongoin
g?
NO
Stop
Date:
Au
g/6/
202
0Changed
Information
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981665
Page 205 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-26-2020 09:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:YESTranscription Error
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981666
Page 206 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 09:24:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/6/2020Changed
Information
Aug-26-2020 09:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981667
Page 207 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.d Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981668
Page 208 of 279
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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-26-2020 08:18:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-26-2020 08:18:54
(UTC-06:00) Central
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
090177e196ae303b\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981669
Page 209
…[truncated]