125742 S1 M5 CRF c4591001 1128 11281009 reissue

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

364

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Page 1 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS ST
AGE 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 COHORTS090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010276
Page 2 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.
Consent Was: OBTAINED
Date Written Consent Obtained
Jul/31/2020090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010277
Page 3 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11281009]
2.
Birth Date: /1954
3. Sex: MALE
4. Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply): WHITE
6. Racial Designation:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
(b) (6)
FDA-CBER-2021-5683-0010278
Page 4 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Jul/31/2020
2. Erroneous Visit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010279
Page 5 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number:
1
Criterion Description: Male or female participants between the a ges of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomizati on (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) EX01A00090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010280
Page 6 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study interv ention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to preven t 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 injec tion
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) EX11A00090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010281
Page 7 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010282
Page 8 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010283
Page 9 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number:
[1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[High Blood Pressure]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOCARDIAL INFARCTION]
Start Date: Jan/1/2017
Ongoing: NO
End Date:Jan/1/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholesterol]
Start Date: UNK/UNK/2001
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2000
Ongoing: YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010284
Page 10 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Bilateral Hip Pain]
Start Date: Nov/17/2014
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[diabetes mellitus type 2]
Start Date: UNK/UNK/1996
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Fluid Retention]
Start Date: UNK/UNK/1995
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Angina intermittent]
Start Date: UNK/UNK/2017
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Restless Leg Syndrome]
Start Date: UNK/UNK/2000
Ongoing: YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010285
Page 11 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[intermittent Non-productive Cough]
Start Date: UNK/UNK/2016
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Vitamin D Deficiency]
Start Date: May/UNK/2020
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Bilateral Hip Replacement]
Start Date: Nov/17/2014
Ongoing: NO
End Date:Nov/17/2014
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Tobacco Dependency]
Start Date: UNK/UNK/1970
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Vasectomy]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:UNK/UNK/1985090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010286
Page 12 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Coronary Arterial Stent placement]
Start Date: Jan/17/2017
Ongoing: NO
End Date:
Jan/17/2017
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Drug Allergy Diphendydramine]
Start Date: UNK/UNK/2005
Ongoing: YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010287
Page 13 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.
Date: Jul/31/2020
2. Weight: [128.59]
3. Unit: kg
4. Height: [190.5]
5. Unit: cm
6. Body Mass Index: [35.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CA VITY090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010288
Page 14 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.
Randomization Date : Jul/31/2020
2. Randomization Number: [221076]
3. Randomization Group: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010289
Page 15 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Jul/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 [BK8CMW]
5.bSample ID [BK8CMX]
5.cSample ID [BN4YCJ]
5.dSample ID [BN4YCK]
5.eSample ID [BN4YCL]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010290
Page 16 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Jul/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 [BN4YDJ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010291
Page 17 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.
Was there a temporary delay of
vaccination?NO
2. Treatment Name [BLINDED THERAPY]
3. Formulation: INJECTION
4. Dose Date Time: Jul/31/2020 16:22
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 OBSERV A TION PERIOD
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010292
Page 18 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.
Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010293
Page 19 of 364
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Aug/19/2020
2. Erroneous Visit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010294
Page 20 of 364
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.W
ere medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010295
Page 21 of 364
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the SubjectDiary 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 SubjectDiary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the SubjectDiary was completed?NO090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010296
Page 22 of 364
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.
Date: Aug/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CA VITY090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010297
Page 23 of 364
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BP9W9R]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010298
Page 24 of 364
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.
Was there a temporary delay of
vaccination?NO
2. Treatment Name [BLINDED THERAPY]
3. Formulation: INJECTION
4. Dose Date Time: Aug/19/2020 15:02
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 OBSERV A TION PERIOD
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010299
Page 25 of 364
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Sep/16/2020
2. Erroneous Visit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010300
Page 26 of 364
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.W
ere medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010301
Page 27 of 364
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the SubjectDiary 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 SubjectDiary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the SubjectDiary was completed?NO090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010302
Page 28 of 364
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BHXNF7]
5.bSample ID [BPR3LJ]
5.cSample ID [BPR3ST]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010303
Page 29 of 364
***Confidential*** 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Not Done
//Comments
2. Erroneous Visit Not Done Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010304
Page 30 of 364
***Confidential*** 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010305
Page 31 of 364
***Confidential*** 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Not Done
//Comments
2. Erroneous Visit Not Done Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010306
Page 32 of 364
***Confidential*** 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010307
Page 33 of 364
***Confidential*** 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Not Done
//Comments
2. Erroneous Visit Not Done Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010308
Page 34 of 364
***Confidential*** 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010309
Page 35 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Nov/28/2020
2. Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3. COVID-19 Illness Visit: COVID_A090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010310
Page 36 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2. Date of First Symptom Started: Not Applicable
//Comments
3. Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
W
as symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
W
as symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
W
as symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010311
Page 37 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms:VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other T
ext: Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010312
Page 38 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
 1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicab
le Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010313
Page 39 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.
Actual Date of Collection: Not Applicable
//Comments
2. Specimen Type: Not Applicable Comments
3. Specimen Collection Location: Not Applicable Comments
4. Assay Code and Description: Not Applicable Comments
5. Device Type: Not Applicable Comments
6. Trade Name: Not Applicable Comments
7. Test Result: Not Applicable Comments
8. Comments/Findings/Details: Not Applicable
[ ]Comments
9. Trade Name Other, Specify: Not Applicable
[ ]Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010314
Page 40 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010315
Page 41 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010316
Page 42 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of V isits or Contacts:
Not Applicable Comments
1.bPhysician or HealthcareProfessional:EMERGENCY ROOM
Occurrence of V isits or Contacts:
Not Applicable Comments
1.cPhysician or HealthcareProfessional:PRIMAR Y CARE PHYSICIAN
Occurrence of V
isits or Contacts: Not Applicable Comments
1.dPhysician or HealthcareProfessional:URGENT CARE
Occurrence of V isits or Contacts:
Not Applicable Comments
1.ePhysician or HealthcareProfessional:TELEPHONE CONSUL TATION
Occurrence of Visits or Contacts: Not Applicable Comments
1 fPhysician or HealthcareProfessional:OTHER
Occurrence of V isits or Contacts:
Not Applicable Comments
Health Care Utilization Other
2.Other T
ype of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized dueto potential COVID-19 illness?Not Applicable
Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010317
Page 43 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treat ment Treatment Start Date Form Instance
 1.     Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010318
Page 44 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Respiratory Treatment
1.
What is the treatment Identifier? [ ]
2. Concomitant Non-drug Treatment
Pre-specified:
3. Treatment:
4. Treatment: [ ]
5. Start Date: //
6. Ongoing?090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010319
Page 45 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Illness Details
1.
Category of Clinical Event: Not Applicable Comments
2. Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3. Toxicity Grade: Not Applicable Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010320
Page 46 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Category of Clinical Event: Subcategory of Clinical Event Diagno sis Obtained Toxicity Grade Form Instance
 1.    Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010321
Page 47 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.
Category of Clinical Event:
2. Subcategory of Clinical Event:
3. Was a diagnosis obtained?4. Toxicity Grade:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010322
Page 48 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen T
ypeLab Result Form Instance
 1.    Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010323
Page 49 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Lab Chemistry Details
1.
Lab Panel:
2. Laboratory Name and Address [ ]
3. Collection Date: //
4. Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:LNMT Low
[ ]
High
[ ]Unit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010324
Page 50 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.    Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010325
Page 51 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Laboratory Data Hematology
1.
Lab Panel:
2. Laboratory Name and Address [ ]
3. Collection Date: //
4. Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:LNMT Low
[ ]
High
[ ]Unit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010326
Page 52 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
 1.  Record Identifier: Systolic: Diastolic:Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010327
Page 53 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.
Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010328
Page 54 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
 1.  Record Identifier: Oxygen SaturationRepeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010329
Page 55 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.
Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010330
Page 56 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction  of Inhaled Oxygen) Form Instance
 1.    Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010331
Page 57 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Oxygenation Parameters
1.
Date Time of Assessment: //
2. Arterial Blood Gases PaO2 (mmHg): [ ]
3. FiO2 (Fraction of Inhaled Oxygen): [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010332
Page 58 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.     Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010333
Page 59 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.
What is the medication identifier? [ ]
2. Category:
3. Concomitant Medications
Pre-specified:
4. Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,formulation).[ ]
5. Start Date: //
6. Ongoing?090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010334
Page 60 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.     Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010335
Page 61 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Imaging
1.
Date of Assessment: //
2. Location of Assessment:
3. Type of Imaging Exam:4. Assessment:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010336
Page 62 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONV ALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Illness Visit
3. COVID-19 Illness Visit:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010337
Page 63 of 364
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. 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 [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010338
Page 64 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010339
Page 65 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1. Assessments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010340
Page 66 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.
Date of Completion/Discontinuation
/Death :Sep/16/2020
2. Phase of Disposition: V ACCINATION
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010341
Page 67 of 364
***Confidential*** 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Follow-Up
1.
Date of Completion/Discontinuation
/Death :Nov/28/2020
2. Phase of Disposition: FOLLOW-UP
3. Status: DEATH
4. Specify Status: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010342
Page 68 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Repeat Swab
3. COVID-19 Repeat Swab:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010343
Page 69 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. 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 [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010344
Page 70 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1 Myocardial Infarct
ion Oct/27/2020 UNK:UNK NO
End Date Time:
Oct/28/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVENT 2 
 Pneumonia Oct/28/2020 UNK:U
NK NO
End Date Time:
Nov/28/2020 06:00
 Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010345
Page 71 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.
Category: ADVERSE EVENT
2. AE ID: [1]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myocardial Infarction]
4. Start Date Time: Oct/27/2020 UNK:UNK
5. Is the adverse event still ongoing? NO
End Date Time:Oct/28/2020 UNK:UNK
6. Toxicity Grade: 4
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or bir th
defect?NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type of medicationerror on the Medication Error Log.NO090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010346
Page 72 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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:[failed cardiac stent]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?Unknown
Comments
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 thestudy?NO
15. Serious Adverse Event Number: For
Pfizer Use Only[2020482043]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010347
Page 73 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.
Category: ADVERSE EVENT
2. AE ID: [2]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pneumonia]
4. Start Date Time: Oct/28/2020 UNK:UNK
5. Is the adverse event still ongoing? NO
End Date Time:Nov/28/2020 06:00
6. Toxicity Grade: 4
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistent orsignificant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disa bility/incapacity?
NO
Is this serious event life threatening?
YES
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]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010348
Page 74 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:FATAL
14. Did the adverse event cause the
subject to be discontinued from the
study?YES
15. Serious Adverse Event Number: For
Pfizer Use Only[2020482043]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010349
Page 75 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.     Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010350
Page 76 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Medication Error
1.
Category:
2. Medication Error (Type of
Medication Error):[ ]
3. Start Date: //
4. Is the medication error still ongoing?
5. Latest Action Taken with Study
Treatment:
6. Was a Concomitant Medication
given?
7. Was a Non-Drug Treatment given?8. Did the Medication Error cause the
subject to be discontinued from the
study?
9. Was this medication error associated
with any adverse events?
10. Serious Adverse Event Number: For
Pfizer Use Only[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010351
Page 77 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.     Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010352
Page 78 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.
What is the medication identifier? [ ]
2. Category:
3. Concomitant Medications
Pre-specified:
4. Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,formulation).[ ]
5. Date: //090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010353
Page 79 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.     Repeating
Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010354
Page 80 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.
What is the medication identifier? [ ]
2. Category:
3. Concomitant Medications
Pre-specified:
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifyinginformation 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?090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010355
Page 81 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Category Treatment Identifier Con Non-Drug Treatments Pre-specif ied Treatment Start Date Form Instance
 1.     Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010356
Page 82 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Radiation Treatment
1.
Category:
2. What is the treatment Identifier? [ ]
3. Concomitant Non-drug Treatment
Pre-specified:
4. Treatment: [ ]
5. Start Date: //
6. Ongoing?090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010357
Page 83 of 364
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.   Repeating Pages090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010358
Page 84 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Transfusion Type:
2.
Date of Transfusion: //090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010359
Page 85 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010360
Page 86 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1. Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010361
Page 87 of 364
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Vaccination
1. Was there a temporary delay of
vaccination?
2. Treatment Name [ ]
3. Formulation:
4. Dose Date Time: //
5. Anatomical Location:6. Body Side:
7. Route:
8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed
11. Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010362
Page 88 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010363
Page 89 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010364
Page 90 of 364
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Not Done
//Comments
2. Erroneous Visit Not Done Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010365
Page 91 of 364
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.
Consent Was: Not Done Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010366
Page 92 of 364
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010367
Page 93 of 364
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
Not Applicable
[ ]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010368
Page 94 of 364
***Confidential*** 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Not Applicable
//Comments
2. Erroneous Visit Not Applicable Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010369
Page 95 of 364
***Confidential*** 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER V ACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.
Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010370
Page 96 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.
Date Treatment Unblinded : Not Applicable
//Comments
2. Primary Reason for Unblinding: Not Applicable Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010371
Page 97 of 364
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.
Withdrawal of Consent Date : Not Applicable
//Comments090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010372
Page 98 of 364
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Death Details
1.
Date of Collection / Notification of
Death:Dec/4/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Pneumonia]090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010373
Page 99 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.
Subject Status DISCONTINUED
2. Subject Status Date Nov/28/2020090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010374
Page 100 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.
Casebook Signature Click Here to Enable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010375
Page 101 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mark Koch Approved Mar-08-2021 16:46:39 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkKoch, 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 electron ic
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.090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010376
Page 102 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Dec-09-2020 17:07:51 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010377
Page 103 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Dec-09-2020 17:07:51 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010378
Page 104 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Dec-09-2020 17:07:51 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010379
Page 105 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-28-2021 16:10:53 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010380
Page 106 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-28-2021 16:10:53 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010381
Page 107 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-28-2021 16:10:53 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010382
Page 108 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Jan-28-2021 16:10:53 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010383
Page 109 of 364
***Confidential***Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Jan-28-2021 16:10:53 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010384
Page 110 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Dec-09-2020 17:08:04 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010385
Page 111 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Dec-09-2020 17:08:04 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010386
Page 112 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Dec-09-2020 17:08:04 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010387
Page 113 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-28-2021 16:11:06 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010388
Page 114 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-28-2021 16:11:06 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010389
Page 115 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-28-2021 16:11:06 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010390
Page 116 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Jan-28-2021 16:11:06 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010391
Page 117 of 364
***Confidential***Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Jan-28-2021 16:11:06 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010392
Page 118 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Dec-09-2020 17:08:17 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010393
Page 119 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Dec-09-2020 17:08:17 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010394
Page 120 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Dec-09-2020 17:08:17 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010395
Page 121 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
Form
Jan-28-2021 16:11:19 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010396
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***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
1
Jan-28-2021 16:11:19 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010397
Page 123 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-28-2021 16:11:19 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010398
Page 124 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Jan-28-2021 16:11:19 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010399
Page 125 of 364
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Jan-28-2021 16:11:19 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010400
Page 126 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
Form
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010401
Page 127 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010402
Page 128 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010403
Page 129 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010404
Page 130 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.a
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010405
Page 131 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4.b
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010406
Page 132 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.c
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010407
Page 133 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.d
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010408
Page 134 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.e
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010409
Page 135 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.f
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010410
Page 136 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.g
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010411
Page 137 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.h
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010412
Page 138 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4.i
Feb-23-2021 11:59:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010413
Page 139 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
Form
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010414
Page 140 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010415
Page 141 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010416
Page 142 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010417
Page 143 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
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Item Date User Comment
4
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010418
Page 144 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
5
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010419
Page 145 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
6
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010420
Page 146 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
7
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010421
Page 147 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
8
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010422
Page 148 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
9
Dec-14-2020 17:09:22 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010423
Page 149 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Feb-23-2021 12:00:43 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010424
Page 150 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Feb-23-2021 12:00:43 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010425
Page 151 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Feb-23-2021 12:00:43 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010426
Page 152 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Feb-23-2021 12:00:43 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010427
Page 153 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Feb-23-2021 12:00:43 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010428
Page 154 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Feb-23-2021 12:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010429
Page 155 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Feb-23-2021 12:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010430
Page 156 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Feb-23-2021 12:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010431
Page 157 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Feb-23-2021 12:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010432
Page 158 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Feb-23-2021 12:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010433
Page 159 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010434
Page 160 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.a
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010435
Page 161 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.b
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010436
Page 162 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.c
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010437
Page 163 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.d
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010438
Page 164 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.e
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010439
Page 165 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1.f
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010440
Page 166 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010441
Page 167 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Feb-23-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010442
Page 168 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Feb-23-2021 12:05:20 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010443
Page 169 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Feb-23-2021 12:05:20 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010444
Page 170 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Feb-23-2021 12:05:20 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010445
Page 171 of 364
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Feb-23-2021 12:05:20 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010446
Page 172 of 364
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
1 Dec-16-2020 09:15:32 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Unknown090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010447
Page 173 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-29-2021 10:12:42 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Done
Form Jan-28-2021 16:11:52 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010448
Page 174 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-29-2021 10:12:42 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done
1 Jan-28-2021 16:11:52 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010449
Page 175 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-29-2021 10:12:42 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done
2 Jan-28-2021 16:11:52 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010450
Page 176 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE -
Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-29-2021 10:13:17 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Done
Form Jan-28-2021 16:12:02 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010451
Page 177 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE -
Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-29-2021 10:13:17 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Done
1 Jan-28-2021 16:12:02 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010452
Page 178 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-28-2021 16:12:12 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010453
Page 179 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-28-2021 16:12:12 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010454
Page 180 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-28-2021 16:12:12 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010455
Page 181 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Jan-28-2021 16:12:12 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010456
Page 182 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Jan-28-2021 16:12:12 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010457
Page 183 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-28-2021 16:12:23 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010458
Page 184 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-28-2021 16:12:23 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010459
Page 185 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-28-2021 16:12:23 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010460
Page 186 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
3
Jan-28-2021 16:12:23 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010461
Page 187 of 364
***Confidential***Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
4
Jan-28-2021 16:12:23 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010462
Page 188 of 364
***Confidential***Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-15-2021 16:46:54 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010463
Page 189 of 364
***Confidential***Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-15-2021 16:46:54 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010464
Page 190 of 364
***Confidential***Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-15-2021 16:46:54 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010465
Page 191 of 364
***Confidential***Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER V ACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-22-2021 16:02:33 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010466
Page 192 of 364
***Confidential***Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER V ACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-22-2021 16:02:33 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010467
Page 193 of 364
***Confidential***Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-22-2021 16:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010468
Page 194 of 364
***Confidential***Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-22-2021 16:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010469
Page 195 of 364
***Confidential***Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
2
Jan-22-2021 16:01:27 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010470
Page 196 of 364
***Confidential***Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
Form
Jan-22-2021 16:02:16 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier
(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010471
Page 197 of 364
***Confidential***Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Item Date User Comment
1
Jan-22-2021 16:02:16 (UTC-06:00) Central Time
(US & Canada)Thea Sonnier(pfe.tsonnier)Not Applicable090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010472
Page 198 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mark Koch Approved Mar-08-2021 16:46:39 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkKoch, 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 electron ic
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.
Jen Vasilio N/A Feb-27-2021 12:19:14 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Mark Koch Approved Feb-24-2021 13:47:12 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.
Thea Sonnier N/A Feb-23-2021 11:55:57 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Mark Koch Approved Jan-31-2021 11:35:04 (UTC-06:00) Central Time
(US & Canada)BOOK Signed090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010473
Page 199 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.
Thea Sonnier N/A Jan-22-2021 16:00:21 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:
N/A
Mark Koch Approved Jan-21-2021 11:46:42 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkKoch, 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 electron ic
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.
Jen Vasilio N/A Jan-13-2021 10:07:19 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Mark Koch Approved Dec-28-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010474
Page 200 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Jen Vasilio N/A Dec-13-2020 05:40:45 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Mark Koch Approved Dec-11-2020 10:10:49 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.
Jen Vasilio N/A Dec-04-2020 15:25:08 (UTC-06:00) Central Time
(US & Canada)Edit - All
signaturesinvalidated
Affidavit:
N/A
Mark Koch Approved Oct-12-2020 10:49:35 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.
Burt Ray N/A Sep-28-2020 13:49:39 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:N/A
Mark Koch Approved Sep-17-2020 17:57:19 (UTC-06:00) Central Time
(US & Canada)BOOK Signed090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010475
Page 201 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MarkKoch, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010476
Page 202 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date
Location User Value Reason
Jul-31-2020 18:17:03
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) 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 18:17:03
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
STAGE 3 COHORTSInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010477
Page 203 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date
Location User Value Reason
Jul-31-2020 18:17:19
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/31/2020Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010478
Page 204 of 364
***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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User
Value Reason
Jul-31-2020 18:16:37
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:11281009Item copied fromprevious form
2. Birth Date:
Date Location User
Value Reason
Jul-31-2020 18:16:33
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User
Value Reason
Jul-31-2020 18:17:30
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:MALEInitial Entry
4. Ethnicity:
Date Location User
Value Reason
Jul-31-2020 18:17:30
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:NOT HISPANIC OR LATINO(A) OR OF SP ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User
Value Reason
Jul-31-2020 18:17:30
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:WHITEInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
(b) (6)
FDA-CBER-2021-5683-0010479
Page 205 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date
Location User Value Reason
Jul-31-2020 18:17:45
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Jul/31/2020Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010480
Page 206 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Inclusion Number:1
Criterion De
scripti
on:Male or female participantsbetween 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
Criter
ion ID
: (ForPfizeruse only):IN01A00Initial Entry
1.a Inclusion Number:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
1Initial Entry
1.a Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomization (dependent upon study stage)Initial Entry
1.a Criterion met?
Date
Location User Value Reason090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010481
Page 207 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
IN01A00Initial Entry
1.b
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Inclusion 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
Criteri
on met?:YES
Criterion ID:(For Pfizer use only)
:IN02A00Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010482
Page 208 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.b Inclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
2Initial Entry
1.b Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study proceduresInitial Entry
1.b Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
IN02A00Initial Entry
1.c
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Inclusion Number:3
Criteri
on Des
cription:Healthy participants who ar
e determined by medical hi
story
, physical examination
, and clinical judgment of the investigator to be eligible for inclusion in the studyInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010483
Page 209 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on met?:YES
Criteri
on ID:
(For Pfizer use only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
3Initial Entry
1.c Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Healthy participants who are determi
ned by medical history
, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
IN03A00Initial Entry
1.d
Date
Location User Value Reason
Jul-31-2020 18:18:07 ACV0PFEINFP6000 Jerred Data Entry: Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010484
Page 210 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
(UTC-06:00) Central Time
(US & Canada)Downs(pfe.jdowns)Inclusion Number:4
Criteri
on Des
cription:Capable of giving personal
signed informed consent, w
hich includes compliancewith the requirements and restrictions listed in the ICDand in this protocol
Criterion met?:YES
Criteri
on ID:
(For Pfizer use only):IN04A00090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010485
Page 211 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.d Inclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
4Initial Entry
1.d Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
IN04A00Initial Entry
2.a
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:1
Criteri
on Des
cription:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participationInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010486
Page 212 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on met?:NO
Criteri
on ID:
(For Pfizer use only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
1Initial Entry
2.a Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or active suicidal ideation/behavior/lab ab
normality that may increase the riskof study participationInitial Entry
2.a Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX01A00Initial Entry
2.b
Date
Location User Value Reason
Jul-31-2020 18:18:07 ACV0PFEINFP6000 Jerred Data Entry: Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010487
Page 213 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
(UTC-06:00) Central Time
(US & Canada)Downs(pfe.jdowns)Exclusion Number:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C virus (HCV), or hepatitis Bvirus (HBV)
Criterion met?:NO
Criterion ID: (For Pfizer
use only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
2Initial Entry
2.b Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis Cvirus (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX02A00Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010488
Page 214 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.c
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:3
Criterion Des
criptio
n:History of severe adverse reaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis)to any component of the study intervention(s)
Criterion met?:NO
Criterion ID:
(For Pf
izer use only):EX03A00Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010489
Page 215 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.c Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
3Initial Entry
2.c Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study intervention(s)Initial Entry
2.c Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX03A00Initial Entry
2.d
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:4
Criterion Description:Receipt of medications intended to preve
nt COVID-19
Criterion met?:NO
Criterion ID:
(For Pfizer use only):EX04A00Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010490
Page 216 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.d Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
4Initial Entry
2.d Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
EX04A00Initial Entry
2.e
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:8
Criterion Description:Immunocompromised individuals with known or suspected immunodeficiency 
,
as determined by history a
nd/or laboratory/physical e
xamination
Criterion met?:NOInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010491
Page 217 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on ID: (For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
8Initial Entry
2.e Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Immunocompromised individuals wi
th known or suspected immunodeficiency
, as determined by history and/o
r laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value ReasonJul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
EX08A00Initial Entry
2.f
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
Exclusi
on Nu
mber:10Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010492
Page 218 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Descriptio
n:Bleeding diathesis or condi
tion associated with prolonged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramuscular injection
Criterion met?:NO
Criterion ID:(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
10Initial Entry
2.f Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
EX10A00Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010493
Page 219 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.g
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:11
Criterion Description:W
omen who are p
regnant or breastfeeding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
11Initial Entry
2.g Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX11A00Initial Entry
2.h
Date
Location User Value Reason090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010494
Page 220 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:12
Criterion Des
cription:Previous vaccination with any coronavi
rus vaccine
Criterion met?:NO
Criterion ID:(For Pfizer use only):EX12A00Initial Entry
2.h Exclusion Number:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
12Initial Entry
2.h Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:EX12A00Initial Entry
2.i
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central TimeACV0PFEINFP6000 Jerred
DownsData Entry:
Exclusio 13Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010495
Page 221 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
(US & Canada) (pfe.jdowns) n Numbe
r:
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agent
s or systemic corticosteroids
Criterionmet?:NO
CriterionID: (ForPfizer use only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
13Initial Entry
2.i Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
Subjects who receive immunosuppre
ssive therapy
, such as cytotoxic agen
ts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX13A01Initial Entry
2.j
Date
Location User Value Reason090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010496
Page 222 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:15
Criterion Description:Receipt of blood/plasma products or immunoglobulin,from 60 days before study intervention administrationor planned receipt throughout the study
Criterion met
?:NO
Criteri
on ID:(For Pfizer useonly):EX14A01Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010497
Page 223 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.j Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
15Initial Entry
2.j Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration o
r planned receipt throughout the studyInitial Entry
2.j Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX14A01Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010498
Page 224 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
2.k
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:16
Criterion Description:Participation in other studies involving study intervention within 28 days prio
r to study entry and/or dur
ing study participation
Criterion met?:NO
Criterion ID: (For Pfizer use only):EX15A01Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010499
Page 225 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.k Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
16Initial Entry
2.k Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during study participationInitial Entry
2.k Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX15A01Initial Entry
2.l
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
ExclusionNumber:17
CriterionDescripti
on:Previous participation in
other studies involving s
tudy intervention containing lipid nanoparticles
Criterionmet?:NOInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010500
Page 226 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
17Initial Entry
2.l Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Previous participation in other studie
s involving study intervention containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
EX16A01Initial Entry
2.m
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Exclusion Number:22Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010501
Page 227 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Criteri
on Des
criptio
n:Investigator site staff or Pfizer employees directly invo
lved in the conduct of the st
udy, site staff otherwise supervised by the investigator,and their respective familymembers
Criterion met
?:NO
Criteri
on ID:(For Pfizer use only):EX21A01090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010502
Page 228 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
2.m Exclusion Number:
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
22Initial Entry
2.m Criterion Description:
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study
, site staff otherwise su
pervised by the investigator, and their respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date
Location User Value Reason
Jul-31-2020 18:18:07
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
EX21A01Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010503
Page 229 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date
Location User Value Reason
Jul-31-2020 18:18:19
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Jul/31/2020Initial Entry
2. Phase of Disposition:
Date
Location User Value Reason
Jul-31-2020 18:18:19
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
SCREENINGInitial Entry
3. Status:
Date
Location User Value Reason
Jul-31-2020 18:18:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
COMPLETEDInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010504
Page 230 of 364
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date
Location User Value Reason
Jul-31-2020 18:18:55
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:1
Medical History Term:High Blood Pressure
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date
Location User Value Reason
Jul-31-2020 18:18:55
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:18:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
High Blood PressureInitial Entry
1.a Start Date:
Date
Location User Value Reason
Jul-31-2020 18:18:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:18:55
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
YESInitial Entry
1.b090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010505
Page 231 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-01-2020 09:06:38
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Line/MH Number:2
Medical History T
erm:MYOCARDIAL INFARCTION
Start Date: Jan/1/2017
Ongoing: NO
End Date:
Jan/1/2017Transcription Error
Jul-31-2020 18:19:23(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Number: 2
Medical History T
er
m:MI
Start Date: Jan/1/2017
Ongoing: NO
End Date:
Jan/1/2017Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010506
Page 232 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:19:23
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Aug-01-2020
10:21:57(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle(pfe.PFETMS)Query 1: Closed Discrepancy has
been closed.
Aug-01-202009:06:38(UTC-06:00)Central Time (US& Canada)ACV0PFEINFP6000 auto query(autoquery)Query 1: AnsweredTranscriptionError
Aug-01-202009:06:38(UTC-06:00)Central Time (US
& Canada)ACV0PFEINFP6000 Jerred Downs
(pfe.jdowns)
Data Entry:
MYOCARDIAL
INF
ARCTIONTranscriptionError
Jul-31-2020
19:36:57
(UTC-06:00)Central Time (US& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle(pfe.PFETMS)Query 1: Opened Clarify the term
MI as follows.Please spell outthe abbreviation inthe term. IfreportingMYOCARDIAL
INFARCTION
then edit to such.Otherwise clarifythe term further.Thank you.
Jul-31-202018:19:23(UTC-06:00)Central Time (US
& Canada)ACV0PFEINFP6000 Jerred Downs
(pfe.jdowns)
Data Entry:
MIInitial Entry
1.b Start Date:090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010507
Page 233 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jul-31-2020 18:19:23
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Jan/1/2017Initial Entry
1.b Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
NO
End Date:
Jan/1/2017Initial Entry
1.c
Date
Location User Value Reason
Jul-31-2020 18:19:52
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 3
Medical History T
er
m:High Cholesterol
Start Date: UNK/UNK/2001
Ongoing: YESInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010508
Page 234 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:19:52
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:19:52
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
High CholesterolInitial Entry
1.c Start Date:
Date
Location User Value Reason
Jul-31-2020 18:19:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/2001Initial Entry
1.c Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:19:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
YESInitial Entry
1.d
Date
Location User Value Reason
Aug-07-2020 12:27:09
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Burt Ray
(pfe.bray2) Data Entry:
Line/MH Number: 4
Medical History T
e
rm:Anxiety
Start Date: UNK/UNK/2000
Ongoing: YESTranscription Error
Jul-31-2020 18:20:08(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Number: 4
Medical History T
e
rm:Anxiety
Start Date: UNK/UNK/1999Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010509
Page 235 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:20:08
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:20:08
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date
Location User Value Reason
Aug-13-2020 11:18:39
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Syed Jafri
(pfe.jafris06)Query 1: Closed Response satisfies
query
Aug-07-2020 12:27:09(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-07-2020 12:27:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Burt Ray
(pfe.bray2)
Data Entry:
UNK/UNK/2000Transcription Error
Aug-04-2020 18:17:20
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 
Syed Jafri
(pfe.jafris06)Query 1: Opened Per source, the start
year is '2000'. Pleaseverify and update,thanks
Jul-31-2020 18:20:08(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)
Data Entry:
UNK/UNK/1999Initial Entry
1.d Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:20:08
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
YESInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010510
Page 236 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.e
Date Location User Value Reason
Jul-31-2020 18:20:36
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 5
Medical History T
e
rm:Bilateral Hip Pain
Start Date: Nov/17/2014
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:20:36
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:20:36
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Bilateral Hip PainInitial Entry
1.e Start Date:
Date
Location User Value Reason
Jul-31-2020 18:20:36
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Nov/17/2014Initial Entry
1.e Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:20:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
YESInitial Entry
1.f
Date
Location User Value Reason
Jul-31-2020 18:21:49
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:6Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010511
Page 237 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:diabetes mellitustype 2
Start Date: UNK/UNK/1996
Ongoing: YES
1.f Line/MH Number:
Date Location User Value ReasonJul-31-2020 18:21:49
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:21:49
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
diabetes mellitus type 2Initial Entry
1.f Start Date:
Date
Location User Value Reason
Jul-31-2020 18:21:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/1996Initial Entry
1.f Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:21:49
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
YESInitial Entry
1.g
Date
Location User Value Reason
Jul-31-2020 18:22:10
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 7
Medical History T
er
m:Fluid Retention
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010512
Page 238 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:22:10
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:22:10
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Fluid RetentionInitial Entry
1.g Start Date:
Date
Location User Value Reason
Jul-31-2020 18:22:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/1995Initial Entry
1.g Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:22:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
YESInitial Entry
1.h
Date
Location User Value Reason
Jul-31-2020 18:22:35
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 8
Medical History Term:Angina intermittent
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010513
Page 239 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:22:35
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:22:35
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Angina intermittentInitial Entry
1.h Start Date:
Date
Location User Value Reason
Jul-31-2020 18:22:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/2017Initial Entry
1.h Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:22:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
YESInitial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010514
Page 240 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.i
Date
Location User Value Reason
Jul-31-2020 18:22:56
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:9
Medical HistoryT
erm:Restless Leg Syndrome
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Jul-31-2020 18:22:56
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Jul-31-2020 18:22:56
(UTC-06:00) Central Time(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns) Data Entry:
Restless Leg SyndromeInitial Entry
1.i Start Date:
Date
Location User Value Reason
Jul-31-2020 18:22:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
UNK/UNK/2000Initial Entry
1.i Ongoing:
Date
Location User Value Reason
Jul-31-2020 18:22:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Jerred
Downs(pfe.jdowns)Data Entry:
YESInitial Entry
1.j
Date
Location User Value Reason090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010515
Page 241 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Aug-19-2020 17:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Alma
Sanchez(pfe.asanchez)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory T
erm:intermittent Non-productive Cough
Start Date: UNK/UNK/2016
Ongoing: YESNew Information
Aug-19-2020 17:31:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Alma
Sanchez(pfe.asanchez) Data Entry:
Line/MH Numb
er:10
Medical History
T
erm:Non-productiveCough
Start Date: UNK/UNK/2016
Ongoing: YESTranscription Error
Aug-19-2020 17:30:44(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Alma
Sanchez(pfe.asanchez)
Data Entry:
Line/MH Number:10
Medical HistoryTerm:Non-productive
Cough
Start Date: UNK/UNK/201
6
Ongoing: YESNew Information(DELETED)
Aug-13-2020 16:57:24(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Thea Sonnier
(pfe.tsonnier)
Data Entry:
Line/MH Number:10
Medical HistoryT
erm:Non-productiveCough
Start Date: UNK/UNK/2016
Ongoing: YESChanged Information
Aug-04-2020 09:48:40(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Jerred Downs
(pfe.jdowns)
Data Entry:
Line/MH Number:10
Medical HistoryT
erm:Non-essentialCough
Start Date: UNK/UNK/2016
Ongoing: YESTranscription Error
Jul-31-2020 18:23:11(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)
Data Entry: Initial Entry090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010516
Page 242 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) Line/MH Number
:10
Medical History T
erm:Cough
Start Date: UNK/UNK/2
016
Ongoing: YES090177e196ae4010\Final\Final On: 01-A pr-2021 05:29 (GMT )
FDA-CBER-2021-5683-0010517
Page 243 of 364
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1128 Site Name: (1128) Ventavia Research Group
Subject No: 11281009 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:31:14
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Alma
Sanchez(
…[truncated]