125742 S1 M5 CRF c4591001 1109 11091074

Document text

Page 1 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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(b) (4)
FDA-CBER-2021-5683-0975802
Page 2 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/31/2020
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975803
Page 3 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091074]
2.Birth Date: /1951
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:
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975804
Page 4 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/31/2020
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975805
Page 5 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975806
Page 6 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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
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(b) (4)
FDA-CBER-2021-5683-0975807
Page 7 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975808
Page 8 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathJul/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0975809
Page 9 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid reflux]
Start Date: Jan/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[SEASONAL Allergy]
Start Date: Jan/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Atrial fibrillation]
Start Date: Jan/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Bladder surgery]
Start Date: Jan/UNK/2004
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cardiac Ablation]
Start Date: Jan/UNK/2005
Ongoing: NO
End Date:
Jan/UNK/2005
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975810
Page 10 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: Jan/UNK/2001
Ongoing: NO
End Date:
Jan/UNK/2001
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: Jan/UNK/2018
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hernia Surgery]
Start Date: Jan/UNK/2002
Ongoing: NO
End Date:
Jan/UNK/2002
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: Jan/UNK/2015
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Irritable Bowel Syndrome-Diarrhea]
Start Date: Jan/UNK/1975
Ongoing: YES
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975811
Page 11 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Jul/31/2020
2.Weight: [127.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [24.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975812
Page 12 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975813
Page 13 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/31/2020
2.Randomization Number: [221173]
3.Randomization Group: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975814
Page 14 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLGG1]
5.bSample ID [BPLGG2]
5.cSample ID [BPLGG3]
5.dSample ID [BPLGG3 ]
5.eSample ID [BPLGG4]
5 fSample ID [BP3RG1]
5.gSample ID [BP3RG2]
5.hSample ID [BP3RG3]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975815
Page 15 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3RG4]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975816
Page 16 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jul/31/2020 15:14
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975817
Page 17 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975818
Page 18 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975819
Page 19 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?YES
Ongoing?
NO
Stop Date:
Aug/6/2020
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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975820
Page 20 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975821
Page 21 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975822
Page 22 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975823
Page 23 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXRP3]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975824
Page 24 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/20/2020 14:09
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975825
Page 25 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975826
Page 26 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975827
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***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975828
Page 28 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BMNGYL]
5.bSample ID [BMNGYM]
5.cSample ID [BPXTYC]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975829
Page 29 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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_A
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975830
Page 30 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/9/2020
2.Date of First Symptom Started: Dec/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/21/2020
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? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975831
Page 31 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Col
lectionSpecimen TypeSpecimen Collectio
n LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/4/2020  SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975832
Page 32 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/4/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975833
Page 33 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/12/2020
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 [RW85943]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975834
Page 34 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Not done per protocol]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975835
Page 35 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: YES
Number of Visits or Contacts:
[1]
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975836
Page 36 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Dec/5/2020  NO
Discharge Date:
Dec/7/2020
 Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975837
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/5/2020
4.Ongoing? NO
Discharge Date:
Dec/7/2020
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975838
Page 38 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975839
Page 39 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975840
Page 40 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/4/2020
3.Toxicity Grade: 4
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975841
Page 41 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975842
Page 42 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975843
Page 43 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for Lab
TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.CLINICAL CHE
MISTRY [ ]  Dec/7/2020  BLOOD Sponsor-Defined I
dentifierTest:Resu
lt:
329  C Reactive Protein_PX3
29 [ ] 
30  Alanine Aminotransfera
se_PX30 14 
28  Aspartate Aminotransfer
ase_PX28 13 
35  Alkaline Phosphatase_P
X35 75 
21  Bilirubin_PX21  0.8 
47  Blood Urea Nitrogen_P
X47 13 
48  Creatinine_PX48  0.7 Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975844
Page 44 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [ ]
3.Collection Date: Dec/7/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [14]
Not Done:
LNMT Low
[5]
High
[55]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [13]
Not Done:
LNMT Low
[5]
High
[34]
Unit
U/L
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975845
Page 45 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [75]
Not Done:
LNMT Low
[40]
High
[150]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.8]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
mg/dL
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.7]
Not Done:
LNMT Low
[0.57]
High
[1.11]
Unit
mg/dL
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975846
Page 46 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.HEMATOLOG
Y [ ]  Dec/7/2020  BLOOD Sponsor-Defined I
dentifierTest:Resu
lt:
1  Hemoglobin_P
X1 9.0 
2  Hematocrit_PX
2 27.2 
3  Erythrocytes_P
X3 [ ] 
5  Platelets_PX5  219 
7  Leukocytes_PX
7 [ ] 
608  Neutrophils_P
X608 65 
609  Eosinophils_P
X609 [ ] 
612  Monocytes_PX
612 0.25 
610  Basophils_PX6
10 [ ] 
611  Lymphocytes_P
X611 11 Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975847
Page 47 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [ ]
3.Collection Date: Dec/7/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [9.0]
Not Done:
LNMT Low
[12.2]
High
[16.2]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [27.2]
Not Done:
LNMT Low
[37.7]
High
[47.9]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975848
Page 48 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [219]
Not Done:
LNMT Low
[142]
High
[424]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [65]
Not Done:
LNMT Low
[39]
High
[77]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975849
Page 49 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.25]
Not Done:
LNMT Low
[0.14]
High
[1.32]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [11]
Not Done:
LNMT Low
[15]
High
[47]
Unit
%
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975850
Page 50 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Dec/6/2020 Record Identifier: Systolic: Diastolic:
1  117  70 Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975851
Page 51 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [117]
Diastolic: [70]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [73]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975852
Page 52 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Dec/6/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975853
Page 53 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975854
Page 54 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975855
Page 55 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975856
Page 56 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975857
Page 57 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975858
Page 58 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Dec/6/2020  CHEST  X-RAY  NORMAL  Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975859
Page 59 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/6/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975860
Page 60 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Jan/15/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975861
Page 61 of 303
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BR7Y62]
5.bSample ID [BSGWXW]
5.cSample ID [BSGWXX]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975862
Page 62 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975863
Page 63 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975864
Page 64 of 303
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975865
Page 65 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975866
Page 66 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975867
Page 67 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975868
Page 68 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Pneumonia COVID-19 ill
ness Dec/4/2020 UNK:U
NK NO
End Date Time:
Dec/21/2020 UNK:UNK
 Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975869
Page 69 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Pneumonia COVID-19 illness]
4.Start Date Time: Dec/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/21/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975870
Page 70 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020490065]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975871
Page 71 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
 1.          Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975872
Page 72 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975873
Page 73 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975874
Page 74 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975875
Page 75 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975876
Page 76 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975877
Page 77 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975878
Page 78 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975879
Page 79 of 303
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975880
Page 80 of 303
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975881
Page 81 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975882
Page 82 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975883
Page 83 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975884
Page 84 of 303
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975885
Page 85 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975886
Page 86 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975887
Page 87 of 303
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975888
Page 88 of 303
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975889
Page 89 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/7/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975890
Page 90 of 303
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975891
Page 91 of 303
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975892
Page 92 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975893
Page 93 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/15/2021
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975894
Page 94 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975895
Page 95 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975896
Page 96 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/15/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975897
Page 97 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BR7Y61]
5.bSample ID [BSGWXT]
5.cSample ID [BSGWXV]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975898
Page 98 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BR7Y68]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975899
Page 99 of 303
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/15/2021 13:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975900
Page 100 of 303
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975901
Page 101 of 303
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975902
Page 102 of 303
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
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 [BRGKG8]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975903
Page 103 of 303
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/5/2021 14:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975904
Page 104 of 303
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975905
Page 105 of 303
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/5/2021
3.Comments: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975906
Page 106 of 303
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975907
Page 107 of 303
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975908
Page 108 of 303
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975909
Page 109 of 303
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975910
Page 110 of 303
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975911
Page 111 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/17/2020
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975912
Page 112 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975913
Page 113 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin  Approved Mar-09-2021 11:46:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975914
Page 114 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormDec-28-2020 07:49:03 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975915
Page 115 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Dec-28-2020 07:49:03 (UTC-05:00) Eastern Time (US
& Canada)Not Done
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975916
Page 116 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Dec-28-2020 07:49:03 (UTC-05:00) Eastern Time (US
& Canada)Not Done
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975917
Page 117 of 303
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Dec-28-2020 07:49:03 (UTC-05:00) Eastern Time (US
& Canada)Not Done
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975918
Page 118 of 303
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormJan-15-2021 15:40:17 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975919
Page 119 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975920
Page 120 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975921
Page 121 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975922
Page 122 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975923
Page 123 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975924
Page 124 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975925
Page 125 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975926
Page 126 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975927
Page 127 of 303
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-05-2021 15:27:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975928
Page 128 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin  Approved Mar-09-2021 11:46:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-05-2021 15:27:20 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Feb-03-2021 14:15:54 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-02-2021 12:34:33 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Jan-22-2021 14:23:33 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975929
Page 129 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, BruceRankin, 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 07:33:59 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Jan-21-2021 16:22:52 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-20-2021 14:52:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Jan-20-2021 14:51:23 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-17-2020 12:11:50 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975930
Page 130 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
N/A
Bruce Rankin  Approved Sep-18-2020 17:51:25 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-18-2020 12:17:25 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Sep-18-2020 08:02:11 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-17-2020 14:49:18 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Sep-14-2020 12:47:05 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975931
Page 131 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-31-2020 17:35:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-31-2020 17:35:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975932
Page 132 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-31-2020 17:35:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/31/2020Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975933
Page 133 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-31-2020 17:34:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11091074Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-31-2020 17:34:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-31-2020 17:35:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-31-2020 17:35:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-31-2020 17:35:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975934
Page 134 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-31-2020 17:35:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975935
Page 135 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants between the
ages of 18 and 55 years, inclusive, 65 a
nd 85 years, inclusive, or 18 and 85 yea
rs, inclusive, at randomization (depende
nt upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975936
Page 136 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusio
n Num
ber:2
Criteri
on Desc
ription:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan
, laboratory tests, lifestyle con
siderations, and other study pr
ocedures
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN02A00Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975937
Page 137 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Inclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vaccin
ation plan, laboratory tests, lifestyle con
siderations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Desc
ription:Healthy participants who are
determined by medical history
, physical examination, and cl
inical judgment of the investi
gator to be eligible for inclusi
on in the study
Criteri
on met
?:YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975938
Page 138 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on ID: (
For Pfi
zer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are determine
d by medical history, physical examinati
on, and clinical judgment of the investig
ator to be eligible for inclusion in the st
udyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusio
n Num
ber:4Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975939
Page 139 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, which
includes compliance with the
requirements and restrictions
listed in the ICD and in this p
rotocol
Criteri
on met?
:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signed infor
med consent, which includes complianc
e with the requirements and restrictions
listed in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-31-2020 17:35:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0975940
Page 140 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric c
ondition incl. recent (within p
ast year) or active suicidal ide
ation/behavior/lab abnormalit
y that may increase the risk of
study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition i
ncl. recent (within past year) or active s
uicidal ideation/behavior/lab abnormalit
y that may increase the risk of study par
ticipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975941
Page 141 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with huma
n immunodeficiency virus (
HIV), hepatitis C virus (HC
V), or hepatitis B virus (HB
V)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human immunod
eficiency 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 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975942
Page 142 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:3
Criterio
n Descr
iption:History of severe adverse rea
ction associated with a vaccin
e and/or severe allergic reacti
on (eg, anaphylaxis) to any co
mponent of the study interven
tion(s)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00Initial Entry
2.c Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reaction assoc
iated with a vaccine and/or severe allerg
ic reaction (eg, anaphylaxis) to any com
ponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975943
Page 143 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended to prev
ent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:8Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975944
Page 144 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criterio
n Descri
ption:Immunocompromised individ
uals with known or suspected
immunodeficiency, as determ
ined by history and/or laborat
ory/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency,
as determined by history and/or laborat
ory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num10Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975945
Page 145 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ber:
Criterio
n Descr
iption:Bleeding diathesis or conditio
n associated with prolonged b
leeding that would, in the opi
nion of the investigator, contr
aindicate intramuscular inject
ion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associat
ed with prolonged bleeding that would,
in the opinion of the investigator, contra
indicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-31-2020 17:35:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0975946
Page 146 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:12
Criterion Descr
iption:Previous vaccination
with any coronavirus
vaccine
Criterion met?: NOInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975947
Page 147 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, suc
h as cytotoxic agents or sys
temic corticosteroids
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975948
Page 148 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.i Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppressi
ve therapy, such as cytotoxic agents or s
ystemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descri
ption:Receipt of blood/plasma prod
ucts or immunoglobulin, fro
m 60 days before study interv
ention administration or plan
ned receipt throughout the stu
dy
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975949
Page 149 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.j Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stud
y intervention administration or planned
receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975950
Page 150 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
2.k
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studies
involving study intervention
within 28 days prior to stud
y entry and/or during study
participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975951
Page 151 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.k Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study parti
cipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in o
ther studies involving stud
y intervention containing l
ipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX16A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975952
Page 152 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.l Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other studies i
nvolving study intervention containing
lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved i
n the conduct of the study, site
staff otherwise supervised by t
he investigator, and their resp
ective family members
Criteri
on met
?:NOInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975953
Page 153 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employe
es directly involved in the conduct of th
e study, site staff otherwise supervised
by the investigator, and their respective
family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 17:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975954
Page 154 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-31-2020 17:36:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-31-2020 17:36:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-31-2020 17:36:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975955
Page 155 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 17:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: Acid reflux
Start Date: Jan/UNK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acid refluxInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-31-2020 17:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-31-2020 17:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-10-2020 13:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 2
Medical History Te
rm:SEASONAL Alle
rgy
Start Date: Jan/UNK/2014Changed Information
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975956
Page 156 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing: YES
Jul-31-2020 17:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term: Allergy
Start Date: Jan/UNK/2014
Ongoing: YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975957
Page 157 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 19:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-11-2020 06:57:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Aug-10-2020 13:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Aug-10-2020 13:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL AllergyChanged Information
Aug-10-2020 10:36:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened The Medical history
CRF is unfrozen.
Please review and
update the details on
Medical history CRF
as appropriate. Thank
you.
Aug-07-2020 09:56:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Data will be amended
to Seasonal Allergies.
Please unlock the page
so data can be
emended.
Aug-06-2020 21:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject is listed to
have 'allergies'. Please
can you update the
verbatim term to
specify what allergies
these are? Thanks
Jul-31-2020 17:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AllergyInitial Entry
1.b Start Date:
Date Location User Value Reason
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (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)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975958
Page 158 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jul-31-2020 17:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-31-2020 17:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-12-2020 07:10:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 3
Medical History Ter
m:Atrial fibrillatio
n
Start Date: Jan/UNK/2015
Ongoing: YESTranscription Error
Jul-31-2020 17:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: A-Fib
Start Date: Jan/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975959
Page 159 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:35:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-12-2020 07:10:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Aug-12-2020 07:10:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Atrial fibrillationTranscription Error
Aug-11-2020 23:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened A-Fib: Please can you
update the verbatim
term to avoid using
abbreviations? Thanks
Jul-31-2020 17:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
A-FibInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-31-2020 17:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-31-2020 17:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-31-2020 17:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: Bladder surgeryInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975960
Page 160 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Start Date: Jan/UNK/2004
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bladder surgeryInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-31-2020 17:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2004Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-31-2020 17:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-31-2020 17:37:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Cardiac Ablation
Start Date: Jan/UNK/2005
Ongoing: NO
End Date:
Jan/UNK/200
5Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975961
Page 161 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:37:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:37:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Cardiac AblationInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-31-2020 17:37:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-31-2020 17:37:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/UNK/2005Initial Entry
1.f
Date Location User Value Reason
Jul-31-2020 17:38:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Cholecystectomy
Start Date: Jan/UNK/2001
Ongoing: NO
End Date:
Jan/UNK/200
1Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975962
Page 162 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:38:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:38:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CholecystectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Jul-31-2020 17:38:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2001Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jul-31-2020 17:38:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/UNK/2001Initial Entry
1.g
Date Location User Value Reason
Jul-31-2020 17:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Term: Depression
Start Date: Jan/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975963
Page 163 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.g Start Date:
Date Location User Value Reason
Jul-31-2020 17:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Jul-31-2020 17:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Jul-31-2020 17:39:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Hernia Surgery
Start Date: Jan/UNK/2002
Ongoing: NO
End Date:
Jan/UNK/200
2Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975964
Page 164 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:39:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:39:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hernia SurgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Jul-31-2020 17:39:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2002Initial Entry
1.h Ongoing:
Date Location User Value Reason
Jul-31-2020 17:39:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/UNK/2002Initial Entry
1.i
Date Location User Value Reason
Jul-31-2020 17:39:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Term: Hypertension
Start Date: Jan/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975965
Page 165 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.i Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:39:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:39:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.i Start Date:
Date Location User Value Reason
Jul-31-2020 17:39:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Jul-31-2020 17:39:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Jul-31-2020 17:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Irritable Bowel Syndro
me-Diarrhea
Start Date: Jan/UNK/1975
Ongoing: YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975966
Page 166 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.j Line/MH Number:
Date Location User Value Reason
Jul-31-2020 17:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-31-2020 17:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Irritable Bowel Syndrome-DiarrheaInitial Entry
1.j Start Date:
Date Location User Value Reason
Jul-31-2020 17:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/1975Initial Entry
1.j Ongoing:
Date Location User Value Reason
Jul-31-2020 17:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975967
Page 167 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
127.0Initial Entry
3. Unit:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.0Initial Entry
7.a
Date Location User Value Reason
Jul-31-2020 17:40:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0975968
Page 168 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-31-2020 17:40:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975969
Page 169 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975970
Page 170 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jul-31-2020 17:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975971
Page 171 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-31-2020 17:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-31-2020 17:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
221173Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975972
Page 172 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 17:41:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 17:41:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-01-2020 06:02:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-31-2020 17:41:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jul-31-2020 17:41:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jul/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-01-2020 06:02:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-01-2020 06:02:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG1Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975973
Page 173 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b
Date Location User Value Reason
Aug-01-2020 06:02:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG2Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-01-2020 06:02:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG2Initial Entry
5.c
Date Location User Value Reason
Aug-01-2020 06:02:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-01-2020 06:02:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG3Initial Entry
5.d
Date Location User Value Reason
Aug-01-2020 06:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG3Transcription Error
(DELETED)
Aug-01-2020 06:03:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG3Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-01-2020 06:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG3Transcription Error
(DELETED)
Aug-01-2020 06:03:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG3Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975974
Page 174 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.e
Date Location User Value Reason
Aug-01-2020 06:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGG4Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-01-2020 06:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGG4Initial Entry
5.f
Date Location User Value Reason
Aug-01-2020 06:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3RG1Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-01-2020 06:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3RG1Initial Entry
5.g
Date Location User Value Reason
Aug-01-2020 06:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3RG2Initial Entry
5.g Sample ID
Date Location User Value Reason
Aug-01-2020 06:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3RG2Initial Entry
5.h
Date Location User Value Reason
Aug-01-2020 06:28:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3RG3Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975975
Page 175 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.h Sample ID
Date Location User Value Reason
Aug-01-2020 06:28:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3RG3Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975976
Page 176 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-31-2020 17:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-31-2020 17:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-01-2020 06:16:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-31-2020 17:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jul-31-2020 17:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jul/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-01-2020 06:16:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3RG4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-01-2020 06:16:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3RG4Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975977
Page 177 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020 15:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jul-31-2020 17:41:26 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975978
Page 178 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-31-2020 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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 17:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975979
Page 179 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jul-31-2020 17:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975980
Page 180 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 16:43:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975981
Page 181 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020 08:08:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUEChanged Information
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975982
Page 182 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:YES
Ongoing
?
NO
Stop
Date:
Aug
/6/2
020
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975983
Page 183 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 02:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-27-2020 08:08:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Aug-27-2020 08:08:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/6/2020Changed Information
Aug-24-2020 11:42:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened e-Diary: Per eDiary
records, FATIGUE is
reported on Last day
however FATIGUE on
the last day in inform
is entered as 'No'.
Please verify and
update. Else, clarify.
Thanks
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975984
Page 184 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.c Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975985
Page 185 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.e Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975986
Page 186 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCLE
PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-20-2020 16:45:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975987
Page 187 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.h Symptom:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:45:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975988
Page 188 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975989
Page 189 of 303
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 16:44:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975990
Page 190 of 303
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Location
::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 16:45:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975991
Page 191 of 303
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975992
Page 192 of 303
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-20-2020 16:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975993
Page 193 of 303
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 15:58:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-20-2020 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 15:58:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXRP3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 15:58:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPXRP3Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975994
Page 194 of 303
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020 14:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020 16:45:49 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975995
Page 195 of 303
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 16:45:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975996
Page 196 of 303
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 14:49:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae3edb\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0975997
Page 197 of 303
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091074 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-17-2020 14:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-17-2020 14:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were
…[truncated]