Document text
Page 1 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039929
Page 2 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/29/2020
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039930
Page 3 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10011093]
2.Birth Date: /1961
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0039931
Page 4 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/29/2020
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039932
Page 5 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039933
Page 6 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039934
Page 7 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039935
Page 8 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039936
Page 9 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039937
Page 10 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: Jun/UNK/2004
Ongoing: NO
End Date:
Jun/UNK/2004
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral cataracts]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/1994
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pectus excavatum]
Start Date: UNK/UNK/1964
Ongoing: NO
End Date:
Jun/UNK/1964
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039938
Page 11 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Torn Anterior cruciate ligament]
Start Date: Dec/UNK/2000
Ongoing: NO
End Date:
Dec/UNK/2000
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia, inguinal, left]
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia, inguinal, right]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039939
Page 12 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/29/2020
2.Weight: [101.1]
3.Unit: kg
4.Height: [189.5]
5.Unit: cm
6.Body Mass Index: [28.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039940
Page 13 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/29/2020
2.Randomization Number: [220088]
3.Randomization Group: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039941
Page 14 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [BP773V]
5.bSample ID [BP773W]
5.cSample ID [BP773X]
5.dSample ID [BMR2HF]
5.eSample ID [BMR2HD]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039942
Page 15 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [BP7736]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039943
Page 16 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 13:15
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039944
Page 17 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039945
Page 18 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039946
Page 19 of 424
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039947
Page 20 of 424
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: 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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039948
Page 21 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: EAR
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039949
Page 22 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP76H8]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039950
Page 23 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 13:00
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039951
Page 24 of 424
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039952
Page 25 of 424
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039953
Page 26 of 424
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: 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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039954
Page 27 of 424
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMR2XM]
5.bSample ID [BMR2XW]
5.cSample ID [BP76RB]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039955
Page 28 of 424
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039956
Page 29 of 424
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]Comments
5.bSample ID Not Applicable
[ ]Comments
5.cSample ID Not Applicable
[ ]Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039957
Page 30 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039958
Page 31 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039959
Page 32 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039960
Page 33 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039961
Page 34 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039962
Page 35 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/13/2021
2.Date of First Symptom Started: Jan/11/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039963
Page 36 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.Symptoms - Other Text: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039964
Page 37 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/13/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039965
Page 38 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/13/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039966
Page 39 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV07749]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039967
Page 40 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[not needed per protocol]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039968
Page 41 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039969
Page 42 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039970
Page 43 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039971
Page 44 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039972
FDA-CBER-2021-5683-0039973
Page 46 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039974
Page 47 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039975
Page 48 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039976
Page 49 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039977
Page 50 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039978
Page 51 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039979
Page 52 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039980
Page 53 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039981
Page 54 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039982
Page 55 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039983
Page 56 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039984
Page 57 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039985
Page 58 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039986
FDA-CBER-2021-5683-0039987
Page 60 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039988
FDA-CBER-2021-5683-0039989
Page 62 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039990
FDA-CBER-2021-5683-0039991
Page 64 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039992
Page 65 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039993
Page 66 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039994
FDA-CBER-2021-5683-0039995
Page 68 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039996
Page 69 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039997
Page 70 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP27G7] Comments
5.bSample ID [BNW7SK] Comments
5.cSample ID [BNW7SL] Comments
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039998
Page 71 of 424
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0039999
Page 72 of 424
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040000
Page 73 of 424
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/21/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040001
Page 74 of 424
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040002
Page 75 of 424
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040003
Page 76 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040004
Page 77 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040005
Page 78 of 424
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Chest Pain Jan/10/2021 12:
09 NO
End Date Time:
Jan/15/2021 UNK:UNK
Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040006
Page 79 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[Chest Pain]
4.Start Date Time: Jan/10/2021 12:09
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040007
Page 80 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:
[cardiac ischemia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021030659]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040008
Page 81 of 424
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040009
Page 82 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040010
Page 83 of 424
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO flu vaccine Sep/14/2
020 Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040011
Page 84 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[flu vaccine]
5.Date: Sep/14/2020
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040012
Page 85 of 424
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040013
Page 86 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040014
FDA-CBER-2021-5683-0040015
Page 88 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040016
FDA-CBER-2021-5683-0040017
Page 90 of 424
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040018
Page 91 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040019
Page 92 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040020
Page 93 of 424
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040021
Page 94 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040022
Page 95 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040023
Page 96 of 424
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040024
Page 97 of 424
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040025
Page 98 of 424
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040026
Page 99 of 424
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040027
Page 100 of 424
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040028
Page 101 of 424
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040029
Page 102 of 424
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040030
Page 103 of 424
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040031
Page 104 of 424
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040032
Page 105 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/21/2020
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040033
Page 106 of 424
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040034
Page 107 of 424
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040035
Page 108 of 424
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aMar-09-2021 11:03:36 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040036
Page 109 of 424
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bMar-09-2021 11:05:04 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040037
Page 110 of 424
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cMar-09-2021 11:05:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040038
Page 111 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040039
Page 112 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040040
Page 113 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040041
Page 114 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040042
Page 115 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040043
Page 116 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040044
Page 117 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jan-26-2021 13:48:22 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040045
Page 118 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-26-2021 13:47:12 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040046
Page 119 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-26-2021 13:47:12 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040047
Page 120 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-26-2021 13:47:12 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040048
Page 121 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-26-2021 13:47:12 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040049
Page 122 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-26-2021 13:47:12 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040050
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040051
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040052
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Page 126 of 424
***Confidential***
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040054
Page 127 of 424
***Confidential***
Header Text: c4591001
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040055
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040056
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***Confidential***
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040057
Page 130 of 424
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040058
Page 131 of 424
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040059
Page 132 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040060
Page 133 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040061
Page 134 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040062
Page 135 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040063
Page 136 of 424
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040064
Page 137 of 424
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040065
Page 138 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040066
Page 139 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040067
Page 140 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040068
Page 141 of 424
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040069
Page 142 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040070
Page 143 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040071
Page 144 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040072
Page 145 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040073
Page 146 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040074
Page 147 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040075
Page 148 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040076
Page 149 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040077
Page 150 of 424
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040078
Page 151 of 424
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040079
Page 152 of 424
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040080
Page 153 of 424
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040081
Page 154 of 424
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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FDA-CBER-2021-5683-0040082
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Site No: 1001 Site Name: (1001) NYU Langone Health
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ItemDate User Comment
5.gJan-26-2021 13:46:45 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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ItemDate User Comment
FormJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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ItemDate User Comment
1Jan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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ItemDate User Comment
2Jan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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ItemDate User Comment
3Jan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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ItemDate User Comment
4Jan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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ItemDate User Comment
5.aJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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ItemDate User Comment
5.aJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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ItemDate User Comment
5.aJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040092
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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5.bJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040096
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040101
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040104
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
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FDA-CBER-2021-5683-0040106
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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FDA-CBER-2021-5683-0040108
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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***Confidential***
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5 fJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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***Confidential***
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
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Page 186 of 424
***Confidential***
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Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-26-2021 13:46:16 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
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5 hJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5 hJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5 hJan-26-2021 13:46:16 (UTC-05:00) Eastern
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Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
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5 hJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.iJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.iJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.iJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.jJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.jJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.jJan-26-2021 13:46:16 (UTC-05:00) Eastern
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5.jJan-26-2021 13:46:16 (UTC-05:00) Eastern
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1Jan-26-2021 13:45:24 (UTC-05:00) Eastern
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2.aJan-26-2021 13:45:24 (UTC-05:00) Eastern
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Subject No: 10011093 Subject Initials: ---
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2.aJan-26-2021 13:45:24 (UTC-05:00) Eastern
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2.aJan-26-2021 13:45:24 (UTC-05:00) Eastern
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Subject No: 10011093 Subject Initials: ---
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1Jan-26-2021 13:45:13 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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2.aJan-26-2021 13:45:13 (UTC-05:00) Eastern
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Subject No: 10011093 Subject Initials: ---
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1Jan-26-2021 13:45:01 (UTC-05:00) Eastern
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2Jan-26-2021 13:45:01 (UTC-05:00) Eastern
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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3Jan-26-2021 13:45:01 (UTC-05:00) Eastern
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Back to Form
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
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1Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Page 216 of 424
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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Page 218 of 424
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Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
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Back to Form
ItemDate User Comment
4Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
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FDA-CBER-2021-5683-0040146
Page 219 of 424
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040147
Page 220 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jan-26-2021 13:44:48 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040148
Page 221 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-26-2021 13:44:32 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Done
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040149
Page 222 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-26-2021 13:44:32 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Done
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040150
Page 223 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-26-2021 13:44:32 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Done
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040151
Page 224 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-26-2021 13:44:32 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Done
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040152
Page 225 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-26-2021 13:44:32 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Done
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040153
Page 226 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aMar-09-2021 09:41:31 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)
5.aFeb-10-2021 13:51:54 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040154
Page 227 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bMar-09-2021 09:42:33 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)
5.bFeb-10-2021 13:52:43 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040155
Page 228 of 424
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cMar-09-2021 09:42:50 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)
5.cFeb-10-2021 13:53:02 (UTC-05:00) Eastern
Time (US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040156
Page 229 of 424
***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, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Nazia Ria N/A Jan-14-2021 11:47:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Oct-11-2020 20:18:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkMulligan, 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.
Mahnoor Ali N/A Sep-21-2020 13:54:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Aug-26-2020 21:12:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkMulligan, 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.
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040157
Page 230 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-29-2020 13:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)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 13:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040158
Page 231 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-29-2020 13:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/29/2020Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040159
Page 232 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-29-2020 13:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10011093Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-29-2020 13:16:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-29-2020 13:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-29-2020 13:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-29-2020 13:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
WHITEInitial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040160
Page 233 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-29-2020 13:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/29/2020Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040161
Page 234 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclusi
ve, at randomization (dep
endent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,
or 18 and 85 years, inclusive, at raInitial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040162
Page 235 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
ndomization (dependent upon stud
y stage)
1.a Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wi
th all scheduled visits, va
ccination plan, laboratory
tests, lifestyle considerati
ons, and other study proc
edures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040163
Page 236 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory t
ests, lifestyle considerations, and
other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040164
Page 237 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgm
ent of the investigator to
be eligible for inclusion i
n the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040165
Page 238 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Healthy participants who are deter
mined by medical history, physica
l examination, and clinical judgme
nt of the investigator to be eligible
for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040166
Page 239 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compl
iance with the requireme
nts and restrictions listed
in the ICD and in this pro
tocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040167
Page 240 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Inclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040168
Page 241 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or activ
e suicidal ideation/behavi
or/lab abnormality that m
ay increase the risk of stu
dy participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040169
Page 242 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepa
titis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040170
Page 243 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040171
Page 244 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with
a vaccine and/or severe a
llergic reaction (eg, anap
hylaxis) to any compone
nt of the study interventi
on(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040172
Page 245 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
History of severe adverse reaction
associated with a vaccine and/or s
evere allergic reaction (eg, anaphy
laxis) to any component of the stu
dy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040173
Page 246 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040174
Page 247 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by h
istory and/or laboratory/
physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040175
Page 248 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histo
ry and/or laboratory/physical exa
minationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040176
Page 249 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pr
olonged bleeding that wo
uld, in the opinion of the
investigator, contraindica
te intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040177
Page 250 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding t
hat would, in the opinion of the in
vestigator, contraindicate intramus
cular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeedingInitial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040178
Page 251 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Women who are pregnant or breas
tfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040179
Page 252 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion De
scription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040180
Page 253 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic cort
icosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040181
Page 254 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.i Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxic
agents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040182
Page 255 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admin
istration or planned recei
pt throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040183
Page 256 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX14A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040184
Page 257 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
2.k
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 da
ys prior to study entry a
nd/or during study parti
cipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040185
Page 258 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.k Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Participation in other studies invol
ving study intervention within 28
days prior to study entry and/or d
uring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040186
Page 259 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nanop
articles
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX16A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040187
Page 260 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040188
Page 261 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m Exclusion Number:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the c
onduct of the study, site staff othe
rwise supervised by the investigat
or, and their respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-29-2020 16:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
EX21A01Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040189
Page 262 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-29-2020 16:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Jul/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-29-2020 16:43:27
(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 16:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040190
Page 263 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020 19:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:appendicitis
Start Date: Jun/UNK/200
4
Ongoing: NO
End Date:
Jun/UNK/2
004Changed
Information
Jul-29-2020 16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:appendicitis
Start Date: Jun/UNK/200
4
Ongoing: NO
End Date:
Jun/UNK/2
004Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-29-2020 16:52:38
(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
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040191
Page 264 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-04-2020 11:17:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Aug-03-2020 19:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe.mali1)Data Entry:
appendicitisChanged
Information
Aug-03-2020 15:57:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jeffrey
Signora
(pfe.signoj01)Query 1: Opened DM QUERY: A
trailing space is
identified. To avoid
processing errors,
please remove the
identified character
by deleting the
entry and
re-entering the data
(without using copy
and paste).
Jul-29-2020 16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
appendicitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-29-2020 16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jun/UNK/2004Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-29-2020 16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NO
End Date:
Jun/UNK/2004Initial Entry
1.b
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040192
Page 265 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-03-2020 19:28:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Numb
er:2
Medical History
Term:bilateral catara
cts
Start Date: UNK/UNK/20
13
Ongoing: NO
End Date:
UNK/UNK/
2020Changed
Information
Jul-29-2020 16:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:bilateral catara
cts
Start Date: UNK/UNK/20
13
Ongoing: NO
End Date:
UNK/UNK/
2020Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040193
Page 266 of 424
***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: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011093 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Jul-29-2020 16:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 11:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:28:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Aug-03-2020 19:28:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe.mali1)Data Entry:
bilateral cataractsChanged
Information
Aug-03-2020 15:57:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jeffrey
Signora
(pfe.signoj01)Query 1: Opened DM QUERY: A
trailing space is
identified. To avoid
processing errors,
please remove the
identified character
by deleting the
entry and
re-entering the data
(without using copy
and paste).
Jul-29-2020 16:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
bilateral cataractsInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-29-2020 16:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
UNK/UNK/2013Initial Entry
090177e196ae2f44\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040194
Page 267 of 424
***Confidential***
Head
…[truncated]