125742 S1 M5 CRF c4591001 1140 11401002

Document text

Page 1 of 265
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983014
Page 2 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/29/2020
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983015
Page 3 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401002]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983016
Page 4 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/29/2020
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983017
Page 5 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon
study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination,
and clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with
the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983018
Page 6 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983019
Page 7 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983020
Page 8 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathJul/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983021
Page 9 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1979
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Spontaneous Coronary artery dissection]
Start Date: Dec/7/2019
Ongoing: NO
End Date:
Dec/31/2019
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1974
Ongoing: YES
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983022
Page 10 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteopenia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983023
Page 11 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Jul/29/2020
2.Weight: Not Done
[ ]Comments
3.Unit: Not Done Comments
4.Height: Not Done
[ ]Comments
5.Unit: Not Done Comments
6.Body Mass Index: [ ]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983024
Page 12 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/29/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983025
Page 13 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/29/2020
2.Randomization Number: [220241]
3.Randomization Group: [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983026
Page 14 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
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 [BPG56X]
5.bSample ID [BPG56Y]
5.cSample ID [BPG56Z]
5.dSample ID [BNB40C]
5.eSample ID [BNB40D]
5 fSample ID [BNB40F]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983027
Page 15 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
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 [BNB408]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983028
Page 16 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/29/2020 14:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983029
Page 17 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983030
Page 18 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983031
Page 19 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983032
Page 20 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983033
Page 21 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983034
Page 22 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983035
Page 23 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYZG4]
5.bSample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983036
Page 24 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/17/2020 09:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983037
Page 25 of 265
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983038
Page 26 of 265
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983039
Page 27 of 265
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983040
Page 28 of 265
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983041
Page 29 of 265
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983042
Page 30 of 265
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983043
Page 31 of 265
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983044
Page 32 of 265
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983045
Page 33 of 265
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983046
Page 34 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983047
Page 35 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983048
Page 36 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983049
Page 37 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983050
Page 38 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983051
Page 39 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983052
Page 40 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983053
Page 41 of 265
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983054
Page 42 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983055
Page 43 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983056
Page 44 of 265
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/17/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Subject no longer wanted to participate after experiencing a spontaneous coronary
artery dissection]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983057
Page 45 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/17/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Subject no longer wanted to participate after experiencing a spontaneous coronary
artery dissection]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983058
Page 46 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983059
Page 47 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983060
Page 48 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  Pain at Injection site  Jul/30/2020 UN
K:UNK NO
End Date Time:
Aug/1/2020 UNK:U
NK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  Diarrhea  Jul/31/2020 UN
K:UNK NO
End Date Time:
Jul/31/2020 UNK:U
NK
 Repeating
Pages
 3. ADVERSE
EVENT 3  Spontaneous coronary ar
tery dissection Aug/28/2020 U
NK:UNK NO
End Date Time:
Aug/28/2020 UNK:
UNK
 Repeating
Pages
 4. ADVERSE
EVENT 4  Myocardial Ischemia  Aug/28/2020 U
NK:UNK NO
End Date Time:
Aug/28/2020 UNK:
UNK
 Repeating
Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983061
Page 49 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at Injection site ]
4.Start Date Time: Jul/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983062
Page 50 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983063
Page 51 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea]
4.Start Date Time: Jul/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jul/31/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983064
Page 52 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983065
Page 53 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Spontaneous coronary artery dissection]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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:
[History of coronary artery dissection]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983066
Page 54 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020363609]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983067
Page 55 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myocardial Ischemia]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Suffered some myocardial ischemia at the time of dissection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983068
Page 56 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983069
Page 57 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.Not Applica
ble Not Applicable
 Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983070
Page 58 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983071
Page 59 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applic
able Repeating
Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983072
Page 60 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983073
Page 61 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983074
Page 62 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983075
Page 63 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicabl
e Not Applicab
le Repeating
Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983076
Page 64 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983077
Page 65 of 265
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983078
Page 66 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983079
Page 67 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983080
Page 68 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983081
Page 69 of 265
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983082
Page 70 of 265
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983083
Page 71 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983084
Page 72 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983085
Page 73 of 265
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983086
Page 74 of 265
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983087
Page 75 of 265
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983088
Page 76 of 265
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983089
Page 77 of 265
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983090
Page 78 of 265
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983091
Page 79 of 265
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983092
Page 80 of 265
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/17/2020
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983093
Page 81 of 265
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983094
Page 82 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/17/2020
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983095
Page 83 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983096
Page 84 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Thomas  Approved Mar-11-2021 11:26:51 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983097
Page 85 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-11-2020 11:27:41 (UTC-05:00) Eastern Time
(US & Canada)vital signs that not collected as per CRF
completion requirement section 4.7
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983098
Page 86 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Aug-17-2020 11:23:10 (UTC-05:00) Eastern Time
(US & Canada)Data not collected in error.
Not Done
2Aug-11-2020 10:31:40 (UTC-05:00) Eastern Time
(US & Canada)data not collected due to error. will be collected at
the following visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983099
Page 87 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-18-2020 13:08:28 (UTC-05:00) Eastern Time
(US & Canada)Data not collected in error
Not Done
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983100
Page 88 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Aug-17-2020 11:23:29 (UTC-05:00) Eastern Time
(US & Canada)Data not collected in error.
Not Done
4Aug-11-2020 10:32:21 (UTC-05:00) Eastern Time
(US & Canada)Data not collected due to error. will be collected at
the following visit
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983101
Page 89 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Aug-18-2020 13:08:40 (UTC-05:00) Eastern Time
(US & Canada)Data not collected in error
Not Done
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983102
Page 90 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-17-2020 13:37:02 (UTC-05:00) Eastern Time
(US & Canada)Subject with documented hysterectomy. Not of
childbearing potential. No pregnancy test
necessary.
Not Done
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983103
Page 91 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983104
Page 92 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983105
Page 93 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983106
Page 94 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983107
Page 95 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983108
Page 96 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983109
Page 97 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983110
Page 98 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983111
Page 99 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983112
Page 100 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983113
Page 101 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Sep-22-2020 12:56:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983114
Page 102 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983115
Page 103 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983116
Page 104 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983117
Page 105 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983118
Page 106 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983119
Page 107 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-22-2020 12:56:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983120
Page 108 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983121
Page 109 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983122
Page 110 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983123
Page 111 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983124
Page 112 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983125
Page 113 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983126
Page 114 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983127
Page 115 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983128
Page 116 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983129
Page 117 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983130
Page 118 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Sep-22-2020 12:56:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983131
Page 119 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983132
Page 120 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983133
Page 121 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983134
Page 122 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983135
Page 123 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983136
Page 124 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983137
Page 125 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-22-2020 12:56:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983138
Page 126 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-22-2020 12:57:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983139
Page 127 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-22-2020 12:57:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983140
Page 128 of 265
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-22-2020 12:57:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983141
Page 129 of 265
***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, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-15-2021 14:56:04 (UTC-05:00) Eastern Time
(US & Canada)not applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983142
Page 130 of 265
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-23-2021 12:52:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983143
Page 131 of 265
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-23-2021 12:52:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983144
Page 132 of 265
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-19-2021 09:47:26 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrawn from study prior to unblinding.
Unblinding captured in paper source and not in
EDC.
Not Applicable
FormFeb-17-2021 14:19:11 (UTC-05:00) Eastern Time
(US & Canada)
FormFeb-15-2021 14:57:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormFeb-11-2021 13:24:01 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-26-2020 13:55:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983145
Page 133 of 265
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-19-2021 09:47:26 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrawn from study prior to unblinding.
Unblinding captured in paper source and not in
EDC.
Not Applicable
1Feb-17-2021 14:19:11 (UTC-05:00) Eastern Time
(US & Canada)
1Feb-15-2021 14:57:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Feb-11-2021 13:24:01 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-26-2020 13:55:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983146
Page 134 of 265
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Feb-19-2021 09:47:26 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrawn from study prior to unblinding.
Unblinding captured in paper source and not in
EDC.
Not Applicable
2Feb-17-2021 14:19:11 (UTC-05:00) Eastern Time
(US & Canada)
2Feb-15-2021 14:57:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Feb-11-2021 13:24:01 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-26-2020 13:55:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983147
Page 135 of 265
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-26-2020 13:56:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983148
Page 136 of 265
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-26-2020 13:56:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983149
Page 137 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Thomas  Approved Mar-11-2021 11:26:51 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-10-2021 12:14:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Dec-15-2020 09:16:32 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-09-2020 13:14:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Nov-17-2020 18:22:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983150
Page 138 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 12:56:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Nov-13-2020 12:29:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 14:54:14 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Oct-27-2020 06:00:16 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983151
Page 139 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
 N/A Oct-26-2020 13:55:50 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Oct-13-2020 16:09:37 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-13-2020 10:54:02 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Sep-24-2020 11:10:20 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-24-2020 10:11:21 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Sep-24-2020 08:29:10 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983152
Page 140 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-24-2020 08:13:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Sep-23-2020 18:29:45 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-23-2020 16:57:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Sep-23-2020 16:33:03 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983153
Page 141 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
 N/A Sep-22-2020 21:25:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Sep-22-2020 15:05:23 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-22-2020 12:24:58 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas  Approved Aug-26-2020 16:42:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983154
Page 142 of 265
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-29-2020 16:57:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-29-2020 16:57:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0983155
Page 143 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-29-2020 16:57:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/29/2020Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0983156
Page 144 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020 21:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event added in AE CRF
Sep-22-2020 12:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Sep-22-2020 06:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020364540
'worsening of spontaneous
coronary artery
dissection'(onset
date:28Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form
Jul-29-2020 16:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11401002Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Jul-29-2020 16:57:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-29-2020 16:58:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983157
Page 145 of 265
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jul-29-2020 16:58:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-29-2020 16:58:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983158
Page 146 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-29-2020 16:58:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983159
Page 147 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and 8
5 years, inclusive, or 18 and
85 years, inclusive, at rando
mization (dependent upon st
udy stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizati
on (dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983160
Page 148 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with a
ll scheduled visits, vaccinat
ion plan, laboratory tests, li
festyle considerations, and
other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983161
Page 149 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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 p
roceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical hi
story, physical examination,
and clinical judgment of the
investigator to be eligible f
or inclusion in the studyInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983162
Page 150 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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 inclus
ion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-29-2020 16:58:44 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983163
Page 151 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance w
ith the requirements and res
trictions listed in the ICD a
nd in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN04A00
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983164
Page 152 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and res
trictions listed in the ICD and in this
protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increas
e the risk of study participat
ionInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983165
Page 153 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or ac
tive suicidal ideation/behavior/lab ab
normality that may increase the risk
of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-29-2020 16:58:44 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983166
Page 154 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vir
us (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983167
Page 155 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis)
to any component of the st
udy intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX03A00Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983168
Page 156 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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 intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983169
Page 157 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.d Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical e
xamination
Criteri
on met
?:NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983170
Page 158 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals wi
th known or suspected immunodefici
ency, as determined by history and/or
laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983171
Page 159 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on Des
criptio
n:Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramus
cular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that w
ould, in the opinion of the investigat
or, contraindicate intramuscular injec
tionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983172
Page 160 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are p
regnant or breastfe
eding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983173
Page 161 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Exclusio 13Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983174
Page 162 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) n Numbe
r:
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agents
or systemic corticosteroi
ds
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agent
s or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983175
Page 163 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Desc
ription:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study i
ntervention administration
or planned receipt through
out the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX14A01Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983176
Page 164 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.j Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration o
r planned receipt throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983177
Page 165 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
2.k
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days prio
r to study entry and/or dur
ing study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983178
Page 166 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.k Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983179
Page 167 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other studie
s involving study intervention contai
ning lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983180
Page 168 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise sup
ervised by the investigator,
and their respective family
members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983181
Page 169 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.m Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise su
pervised by the investigator, and thei
r respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983182
Page 170 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-29-2020 16:58:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-29-2020 16:58:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-29-2020 16:58:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983183
Page 171 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Jul-29-2020 16:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/19
79
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-29-2020 16:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 16:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-29-2020 16:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-29-2020 16:59:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983184
Page 172 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jul-29-2020 17:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Hyperlipidemi
a
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Jul-29-2020 17:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 17:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-29-2020 17:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-29-2020 17:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-24-2020 10:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Spontaneous Coronar
y artery dissectionUpdated as per
safety unit query
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0983185
Page 173 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: Dec/7/2019
Ongoing: NO
End Date:
Dec/31/2019
Jul-29-2020 17:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Spontaneous Coronar
y artery dissection
Start Date: Dec/7/2019
Ongoing: YESInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983186
Page 174 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Jul-29-2020 17:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 17:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Spontaneous Coronary artery dissecti
onInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-29-2020 17:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-24-2020 10:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/31/2019Updated as per
safety unit query
Jul-29-2020 17:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-29-2020 17:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Seasonal Allerg
ies
Start Date: UNK/UNK/19
74
Ongoing: YESInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983187
Page 175 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Jul-29-2020 17:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 17:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-29-2020 17:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1974Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-29-2020 17:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-29-2020 17:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Osteopenia
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983188
Page 176 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Jul-29-2020 17:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-29-2020 17:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OsteopeniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-29-2020 17:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-29-2020 17:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983189
Page 177 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 15:51:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Saumitra
DubeyQuery 1: Closed Response satisfies
query
Aug-18-2020 13:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-14-2020 06:55:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Re-Query: Thanks
for confirming that
assessment is not
done. Please go to
item level comment
and select "not done"
for reason
incomplete section.
This should be done
for all missing data.
Please update the
data, else clarify.
Jul-29-2020 17:03:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 11:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Aug-12-2020 04:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-11-2020 10:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Comment updated
per query
Aug-10-2020 04:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM Requery:
Thanks for the
response. Please
indicate an item
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983190
Page 178 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
level comment for
the vital signs that
not collected as per
CRF completion
requirement section
4.7 to remove the
blank flag.
Aug-07-2020 09:35:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Not collected in
error. Will be
collected at
following visit.
Jul-31-2020 06:14:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Vital signs date has
complete, however,
Weight, Height and
units are
incomplete. Could
you please provide
the data.
3. Unit:
Date Location User Value Reason
Aug-18-2020 13:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 11:23:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 13:08:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7.a
Date Location User Value Reason
Jul-29-2020 17:03:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Record Identifier:: 1Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983191
Page 179 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) Temperature: 98.2
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Jul-29-2020 17:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-29-2020 17:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-29-2020 17:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-29-2020 17:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983192
Page 180 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-29-2020 17:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-29-2020 17:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-29-2020 17:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-29-2020 17:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-29-2020 17:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jul-29-2020 17:03:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983193
Page 181 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Jul-29-2020 17:03:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-29-2020 17:03:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jul-29-2020 17:03:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983194
Page 182 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-29-2020 17:03:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-30-2020 13:58:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
220241Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983195
Page 183 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-29-2020 17:03:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-29-2020 17:03:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 13:30:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jul-30-2020 05:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-29-2020 17:03:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-29-2020 17:03:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jul/29/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983196
Page 184 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-05-2020 13:42:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-05-2020 13:31:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UPDATED PER SDInitial Entry
5.a
Date Location User Value Reason
Aug-05-2020 13:30:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG56XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 13:30:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPG56XInitial Entry
5.b
Date Location User Value Reason
Aug-05-2020 13:30:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG56YInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 13:30:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPG56YInitial Entry
5.c
Date Location User Value Reason
Aug-05-2020 13:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG56ZInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983197
Page 185 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 13:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPG56ZInitial Entry
5.d
Date Location User Value Reason
Aug-05-2020 13:44:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNB40CInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 13:44:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNB40CInitial Entry
5.e
Date Location User Value Reason
Aug-05-2020 13:44:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNB40DInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 13:44:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNB40DInitial Entry
5.f
Date Location User Value Reason
Aug-05-2020 13:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNB40FInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983198
Page 186 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.f Sample ID
Date Location User Value Reason
Aug-05-2020 13:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNB40FInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983199
Page 187 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-29-2020 17:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-29-2020 17:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 11:49:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jul-30-2020 05:56:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-29-2020 17:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-29-2020 17:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jul/29/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983200
Page 188 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-05-2020 13:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-05-2020 11:49:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UPDATED PER SDInitial Entry
5.a
Date Location User Value Reason
Aug-05-2020 11:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNB408Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 11:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNB408Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983201
Page 189 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020 14:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983202
Page 190 of 265
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jul-29-2020 17:04:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0983203
Page 191 of 265
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-10-2020 02:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-07-2020 09:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Aug-07-2020 09:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
Jul-31-2020 06:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened REACTOGENICITY
DIARY is incomplete.
Could you please
provide the data
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0983204
Page 192 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 13:35:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983205
Page 193 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983206
Page 194 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983207
Page 195 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.d
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983208
Page 196 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.e Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983209
Page 197 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983210
Page 198 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983211
Page 199 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SIInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983212
Page 200 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
TE
Were injection site react
ions present on the last d
ay the Subject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-17-2020 13:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983213
Page 201 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2.a
Date Location User Value Reason
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983214
Page 202 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-17-2020 13:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983215
Page 203 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-17-2020 13:37:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020 13:37:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Define
d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done::Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020 13:37:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983216
Page 204 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 13:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 13:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 11:10:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-18-2020 11:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened There are more than
1 barcode present for
sample collection.
Please review and
correct as
appropriate.
Aug-18-2020 11:10:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 02:40:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM Query: 'Sample
Collected?' is Yes,
however no barcodes
are entered. Please
review and correct as
appropriate.
Aug-17-2020 13:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983217
Page 205 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-17-2020 13:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020 11:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYZG4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 11:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYZG4Initial Entry
5.b
Date Location User Value Reason
Aug-18-2020 11:11:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
(DELETED)
Aug-18-2020 11:10:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Aug-18-2020 11:10:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYZG5Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983218
Page 206 of 265
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Sample ID
Date Location User Value Reason
Aug-18-2020 11:11:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
(DELETED)
Aug-18-2020 11:10:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-18-2020 11:10:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYZG5Initial Entry
090177e196ae30f7\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983219
Page 207 of 265
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back t
…[truncated]