Document text
Page 1 of 313
***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: 10011100 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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040353
Page 2 of 313
***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: 10011100 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/30/2020
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040354
Page 3 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10011100]
2.Birth Date: /1951
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040355
Page 4 of 313
***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: 10011100 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/30/2020
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040356
Page 5 of 313
***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: 10011100 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
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040357
Page 6 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040358
Page 7 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040359
Page 8 of 313
***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: 10011100 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/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040360
Page 9 of 313
***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: 10011100 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:[dyslipidemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040361
Page 10 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [62.6]
3.Unit: kg
4.Height: [165.1]
5.Unit: cm
6.Body Mass Index: [23.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: EAR
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040362
Page 11 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040363
Page 12 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/30/2020
2.Randomization Number: [220395]
3.Randomization Group: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040364
Page 13 of 313
***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: 10011100 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/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMR2HW]
5.bSample ID [BMR2HX]
5.cSample ID [BP775T]
5.dSample ID [BP775V]
5.eSample ID [BP775W]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040365
Page 14 of 313
***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: 10011100 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/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP774W]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040366
Page 15 of 313
***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: 10011100 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/30/2020 12:04
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040367
Page 16 of 313
***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: 10011100 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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040368
Page 17 of 313
***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: 10011100 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/18/2020
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040369
Page 18 of 313
***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: 10011100 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
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040370
Page 19 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040371
Page 20 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040372
Page 21 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040373
Page 22 of 313
***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: 10011100 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/18/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP76H3]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040374
Page 23 of 313
***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: 10011100 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/18/2020 11:19
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040375
Page 24 of 313
***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: 10011100 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/22/2020
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040376
Page 25 of 313
***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: 10011100 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
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040377
Page 26 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040378
Page 27 of 313
***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: 10011100 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/22/2020
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 [BNW7KF]
5.bSample ID [BNW7KN]
5.cSample ID [BNW7KP]
5.dSample ID [BP76RT]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040379
Page 28 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040380
Page 29 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040381
Page 30 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040382
Page 31 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040383
Page 32 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040384
Page 33 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040385
Page 34 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040386
Page 35 of 313
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040387
Page 36 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: 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: 10011100 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/31/2020
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040388
Page 37 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: 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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040389
Page 38 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: 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: 10011100 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/31/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040390
Page 39 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040391
Page 40 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Aug/31/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: YES
Maximum Diameter (cm):
[4.0]
Minimum Diameter (cm):
[2.0]
Meets Grade 4 Reaction Criteria:
NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040392
Page 41 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: NO
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040393
Page 42 of 313
***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: 10011100 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/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040394
Page 43 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040395
Page 44 of 313
***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: 10011100 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:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040396
Page 45 of 313
***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: 10011100 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 [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040397
Page 46 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 macular rash on neck Aug/10/2020
UNK:UNK NO
End Date Time:
Aug/25/2020 UN
K:UNK
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 Dermatitis with red patch on left
abdomen Aug/10/2020
UNK:UNK NO
End Date Time:
Sep/9/2020 UNK:
UNK
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 Dermatitis with red patch on righ
t breast Aug/10/2020
UNK:UNK NO
End Date Time:
Sep/9/2020 UNK:
UNK
Repeating
Pages
4. DELETED ADVERSE
EVENT 4 Dermatitis with red patch from le
ft areola extending laterally Aug/10/2020
UNK:UNK NO
End Date Time:
Sep/9/2020 UNK:
UNK
Repeating
Pages
5. ADVERSE
EVENT 5 Dermatitis of trunk Aug/25/2020
UNK:UNK NO
End Date Time:
Sep/3/2020 UNK:
UNK
Repeating
Pages
6. ADVERSE
EVENT 6 poison ivy Aug/11/2020
UNK:UNK NO
End Date Time:
Aug/31/2020 UN
K:UNK
Repeating
Pages
7. ADVERSE
EVENT 7 R 5th metatarsal fracture Dec/12/2020
UNK:UNK YES Repeating
Pages
8. ADVERSE
EVENT 8 L radial head fracture Dec/12/2020
UNK:UNK YES Repeating
Pages
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040398
Page 47 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
9. ADVERSE
EVENT 9 R pinky finger trigger finger Jan/1/2021 U
NK:UNK YES Repeating
Pages
10. ADVERSE
EVENT 10 fall Dec/12/2020
UNK:UNK NO
End Date Time:
Dec/12/2020 UN
K:UNK
Repeating
Pages
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040399
Page 48 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[macular rash on neck ]
4.Start Date Time: Aug/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[poison ivy ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040400
Page 49 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040401
Page 50 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dermatitis with red patch on left abdomen ]
4.Start Date Time: Aug/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unspecified ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040402
Page 51 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040403
Page 52 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dermatitis with red patch on right breast ]
4.Start Date Time: Aug/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unspecified non-allergy ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040404
Page 53 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040405
Page 54 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dermatitis with red patch from left areola extending laterally ]
4.Start Date Time: Aug/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unspecified non-allergic reaction ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040406
Page 55 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040407
Page 56 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dermatitis of trunk]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[poison ivy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040408
Page 57 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040409
Page 58 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[poison ivy]
4.Start Date Time: Aug/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[exposure to poison ivy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040410
Page 59 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040411
Page 60 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[R 5th metatarsal fracture]
4.Start Date Time: Dec/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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
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:
[Participant tripped and fell down]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040412
Page 61 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021139022]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040413
Page 62 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[L radial head fracture]
4.Start Date Time: Dec/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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
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:
[Participant tripped and fell down]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040414
Page 63 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021139022]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040415
Page 64 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[R pinky finger trigger finger]
4.Start Date Time: Jan/1/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[R pinky finger trigger finger]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040416
Page 65 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040417
Page 66 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Dec/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/12/2020 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?
YES
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040418
Page 67 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040419
Page 68 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040420
Page 69 of 313
***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: 10011100 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[ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040421
Page 70 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040422
Page 71 of 313
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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.Date: //
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040423
Page 72 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040424
Page 73 of 313
***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: 10011100 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?
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040425
FDA-CBER-2021-5683-0040426
Page 75 of 313
***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: 10011100 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?
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040427
FDA-CBER-2021-5683-0040428
Page 77 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040429
Page 78 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040430
Page 79 of 313
***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: 10011100 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:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040431
Page 80 of 313
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040432
Page 81 of 313
***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: 10011100 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?
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040433
Page 82 of 313
***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: 10011100 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: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040434
Page 83 of 313
***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: 10011100 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: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040435
Page 84 of 313
***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: 10011100 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/15/2021
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040436
Page 85 of 313
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040437
Page 86 of 313
***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: 10011100 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/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040438
Page 87 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040439
Page 88 of 313
***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: 10011100 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: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040440
Page 89 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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/20/2021
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040441
Page 90 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040442
Page 91 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040443
Page 92 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040444
Page 93 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040445
Page 94 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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:
Jan/20/2021
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 [BP27DN]
5.bSample ID [BNW7R0]
5.cSample ID [BNW7NP]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040446
Page 95 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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:
Jan/20/2021
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 [BP27DL]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040447
Page 96 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 12:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040448
Page 97 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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/8/2021
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040449
Page 98 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040450
Page 99 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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:
Feb/8/2021
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 [BP27FN]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040451
Page 100 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 12:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040452
Page 101 of 313
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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 Mar/8/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040453
Page 102 of 313
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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:
Mar/8/2021
3.Comments: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040454
Page 103 of 313
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040455
Page 104 of 313
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040456
Page 105 of 313
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040457
Page 106 of 313
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040458
Page 107 of 313
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040459
Page 108 of 313
***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: 10011100 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/22/2020
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040460
Page 109 of 313
***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: 10011100 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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040461
Page 110 of 313
***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: 10011100 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
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040462
Page 111 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormFeb-19-2021 16:50:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040463
Page 112 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Feb-19-2021 16:50:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040464
Page 113 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Feb-19-2021 16:50:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040465
Page 114 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Feb-19-2021 16:50:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040466
Page 115 of 313
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Feb-19-2021 16:50:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040467
Page 116 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-21-2021 11:56:44 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040468
Page 117 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormFeb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040469
Page 118 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Feb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040470
Page 119 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Feb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040471
Page 120 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Feb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
3Jan-26-2021 13:46:00 (UTC-05:00) Eastern Time
(US & Canada)Gali Moritz
(pfe.gmoritz)Not Done
3Jan-21-2021 11:57:08 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040472
Page 121 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Feb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040473
Page 122 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Feb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040474
Page 123 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040475
Page 124 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
6.aJan-22-2021 12:10:14 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040476
Page 125 of 313
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-01-2021 15:21:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Done
6.aJan-22-2021 12:10:36 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040477
Page 126 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Feb-08-2021 17:07:32 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040478
Page 127 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:07:50 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040479
Page 128 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:07:50 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040480
Page 129 of 313
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:07:50 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe nria)Not Applicable
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040481
Page 130 of 313
***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: 10011100 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
Gali Moritz N/A Jan-20-2021 15:43:08 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Oct-11-2020 20:22:34 (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.
Gali Moritz N/A Oct-08-2020 10:22:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Vanessa Raabe Approved Sep-23-2020 17:03:19 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, VanessaRaabe, 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.
Sara Hyman N/A Sep-22-2020 16:00:06 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040482
Page 131 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
Vanessa Raabe Approved Sep-16-2020 16:07:40 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, VanessaRaabe, 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.
Akeem Moore N/A Sep-16-2020 13:15:22 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Sep-11-2020 11:45:59 (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.
Akeem Moore N/A Sep-08-2020 19:12:59 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Sep-03-2020 17:57:30 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040483
Page 132 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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.
Akeem Moore N/A Sep-03-2020 13:40:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Sep-01-2020 13:21:11 (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.
Akeem Moore N/A Aug-31-2020 16:20:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan Approved Aug-27-2020 09:46:17 (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.
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040484
Page 133 of 313
***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: 10011100 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-30-2020 12:35:14
(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-30-2020 12:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040485
Page 134 of 313
***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: 10011100 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-30-2020 12:35:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040486
Page 135 of 313
***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: 10011100 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-30-2020 12:35:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jul-30-2020 12:35:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
10011100Transcription Error
Jul-30-2020 12:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Subject ID is
expected to be in 8
digits. Please review.
Jul-30-2020 12:35:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1100Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 12:35:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 12:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-30-2020 12:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-30-2020 12:35:36 ACV0PFEINFP6000 Sara Hyman Data Entry: Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040487
Page 136 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)(pfe.shyman) WHITE
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040488
Page 137 of 313
***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: 10011100 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-30-2020 12:36:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040489
Page 138 of 313
***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: 10011100 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-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Inclusi
on Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 an
d 85 years, inclusive, at ran
domization (dependent upo
n study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizat
ion (dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040490
Page 139 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests,
lifestyle considerations, an
d other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040491
Page 140 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Inclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Participants who are willing and abl
e to comply with all scheduled visits
, vaccination plan, laboratory tests, li
festyle considerations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical hi
story, physical examination
, and clinical judgment of t
he investigator to be eligibl
e for inclusion in the studyInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040492
Page 141 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclu
sion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-30-2020 12:36:24 ACV0PFEINFP6000 Sara Hyman Data Entry: Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040493
Page 142 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)(pfe.shyman) Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes compliance
with the requirements and r
estrictions listed in the ICD
and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040494
Page 143 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Inclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increa
se the risk of study particip
ationInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040495
Page 144 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or a
ctive suicidal ideation/behavior/lab a
bnormality that may increase the ris
k of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-30-2020 12:36:24 ACV0PFEINFP6000 Sara Hyman Data Entry: Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040496
Page 145 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)(pfe.shyman) Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vi
rus (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX02A00Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040497
Page 146 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis
) to any component of the s
tudy intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX03A00Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040498
Page 147 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or sever
e allergic reaction (eg, anaphylaxis) t
o any component of the study interv
ention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040499
Page 148 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical e
xamination
Criteri
on met
?:NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040500
Page 149 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Immunocompromised individuals wi
th known or suspected immunodefici
ency, as determined by history and/o
r laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040501
Page 150 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramu
scular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Bleeding diathesis or condition asso
ciated with prolonged bleeding that
would, in the opinion of the investig
ator, contraindicate intramuscular inj
ectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX10A00Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040502
Page 151 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are p
regnant or breastfe
eding
Criterion met?: NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040503
Page 152 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusio 13Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040504
Page 153 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) n Numbe
r:
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic agen
ts or systemic corticoster
oids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agen
ts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040505
Page 154 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study
intervention administration
or planned receipt through
out the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX14A01Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040506
Page 155 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration o
r planned receipt throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX14A01Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040507
Page 156 of 313
***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: 10011100 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-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040508
Page 157 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.k Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040509
Page 158 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Previous participation in other studi
es involving study intervention cont
aining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040510
Page 159 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise su
pervised by the investigator
, and their respective famil
y members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040511
Page 160 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m Exclusion Number:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 12:36:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EX21A01Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040512
Page 161 of 313
***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: 10011100 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-30-2020 12:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-30-2020 12:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-30-2020 12:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040513
Page 162 of 313
***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: 10011100 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 19:30:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Number: 1
Medical History Te
rm:dyslipidemia
Start Date: UNK/UNK/20
00
Ongoing: YESChanged Information
Jul-30-2020 15:23:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:dyslipidemia
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 15:23:28
(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
Aug-04-2020 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:30:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Aug-03-2020 19:30:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe mali1)Data Entry:
dyslipidemiaChanged Information
Aug-03-2020 16:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jeffrey
Signora
(pfe.signoj01)Query 1: Opened DM QUERY: A
trailing space is
identified. To avoid
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040514
Page 163 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
processing errors,
please remove the
identified character
by deleting the entry
and re-entering the
data (without using
copy and paste).
Jul-30-2020 15:23:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
dyslipidemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 15:23:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 15:23:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-03-2020 19:31:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Number: 2
Medical History Te
rm:hypertension
Start Date: UNK/UNK/20
00
Ongoing: YESChanged Information
Jul-30-2020 15:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:hypertension
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040515
Page 164 of 313
***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: 10011100 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-30-2020 15:23:53
(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 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Aug-03-2020 19:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe mali1)Data Entry:
hypertensionChanged Information
Aug-03-2020 16:02:30
(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-30-2020 15:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 15:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040516
Page 165 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 15:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-03-2020 19:31:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Number: 3
Medical History Te
rm:osteoarthritis
Start Date: UNK/UNK/20
18
Ongoing: YESChanged Information
Jul-30-2020 15:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:osteoarthritis
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040517
Page 166 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Jul-30-2020 15:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Aug-03-2020 19:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe mali1)Data Entry:
osteoarthritisChanged Information
Aug-03-2020 16:02:42
(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-30-2020 15:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
osteoarthritisInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-30-2020 15:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040518
Page 167 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 15:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-03-2020 19:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mahnoor
Ali
(pfe.mali1)Data Entry:
Line/MH Number: 4
Medical History Te
rm:seasonal allerg
ies
Start Date: UNK/UNK/20
17
Ongoing: YESChanged Information
Jul-30-2020 15:24:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:seasonal allerg
ies
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040519
Page 168 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Jul-30-2020 15:24:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1: Closed Response satisfies
query
Aug-03-2020 19:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Aug-03-2020 19:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mahnoor Ali
(pfe mali1)Data Entry:
seasonal allergiesChanged Information
Aug-03-2020 16:02:56
(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-30-2020 15:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
seasonal allergiesInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-30-2020 15:24:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040520
Page 169 of 313
***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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 15:24:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040521
Page 170 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
62.6Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
165.1Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.0Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040522
Page 171 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7.a
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-30-2020 15:25:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
EARInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040523
Page 172 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040524
Page 173 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jul-30-2020 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOT DONEInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040525
Page 174 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-30-2020 12:36:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-30-2020 16:03:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
220395Transcription Error
Jul-30-2020 12:36:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry: Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040526
Page 175 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 12:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 12:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 16:54:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 12:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-30-2020 12:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 16:54:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BMR2HWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040527
Page 176 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 16:54:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BMR2HWInitial Entry
5.b
Date Location User Value Reason
Jul-30-2020 16:54:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BMR2HXInitial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020 16:54:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BMR2HXInitial Entry
5.c
Date Location User Value Reason
Jul-30-2020 18:29:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP775TInitial Entry
5.c Sample ID
Date Location User Value Reason
Jul-30-2020 18:29:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BP775TInitial Entry
5.d
Date Location User Value Reason
Jul-30-2020 18:29:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP775VInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040528
Page 177 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Jul-30-2020 18:29:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BP775VInitial Entry
5.e
Date Location User Value Reason
Jul-30-2020 18:29:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP775WInitial Entry
5.e Sample ID
Date Location User Value Reason
Jul-30-2020 18:29:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BP775WInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040529
Page 178 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 12:37:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 12:37:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 16:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 12:37:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jul-30-2020 12:37:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 16:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP774WInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040530
Page 179 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 16:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BP774WInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040531
Page 180 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Jul/30/2020 12:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
LEFTInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040532
Page 181 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7. Route:
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jul-30-2020 12:37:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040533
Page 182 of 313
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jul-30-2020 12:37:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040534
Page 183 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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
Aug-18-2020 13:21:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/18/2020Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040535
Page 184 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040536
Page 185 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040537
Page 186 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040538
Page 187 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040539
Page 188 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040540
Page 189 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040541
Page 190 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Injection Site Reaction:: PAIN A
T INJE
CTIONInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040542
Page 191 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
SITE
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-18-2020 13:22:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040543
Page 192 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 13:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/18/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020 10:22:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Gali Moritz
(pfe.gmoritz)Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYTranscription Error
Aug-18-2020 13:23:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Location:: EARChanged Information
Aug-18-2020 13:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 13:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-18-2020 13:22:49
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Akeem
MooreData Entry:
36.9Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040544
Page 193 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe.amoore1)
2.a Unit:
Date Location User Value Reason
Aug-18-2020 13:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-08-2020 10:22:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Gali Moritz
(pfe.gmoritz)Data Entry:
ORAL CAVITYTranscription Error
Aug-18-2020 13:23:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
EARChanged Information
Aug-18-2020 13:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040545
Page 194 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040546
Page 195 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-18-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOT DONEInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040547
Page 196 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 11:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 11:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 04:51:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sanjay Mishra
(pfe.mishrs01)Query 1: Closed Response satisfies
query
Aug-19-2020 11:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Aug-19-2020 11:45:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
Aug-19-2020 11:21:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Saumitra
Dubey
(pfe.dubeys27)Query 1: Opened Please provide the
missing data.
5.a
Date Location User Value Reason
Aug-18-2020 15:46:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP76H3Initial Entry
5.a Sample ID
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040548
Page 197 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-18-2020 15:46:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
BP76H3Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040549
Page 198 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/18/2020 11:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
LEFTInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040550
Page 199 of 313
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7. Route:
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-18-2020 13:31:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Akeem
Moore
(pfe.amoore1)Data Entry:
YESInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040551
Page 200 of 313
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011100 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
Sep-22-2020 16:00:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040552
Page 201 of 313
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040553
Page 202 of 313
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 10011100 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 16:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
090177e196ae2f42\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040554
Page 203 of 313
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L For
…[truncated]