125742 S1 M5 CRF c4591001 1001 10011135

Document text

Page 1 of 174
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040666
Page 2 of 174
***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: 10011135 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
Aug/5/2020
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040667
Page 3 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10011135]
2.Birth Date: /1975
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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040668
Page 4 of 174
***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: 10011135 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/5/2020
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040669
Page 5 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040670
Page 6 of 174
***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: 10011135 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
/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040671
Page 7 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040672
Page 8 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [56.5]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [19.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040673
Page 9 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040674
Page 10 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [43218]
3.Randomization Group: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040675
Page 11 of 174
***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: 10011135 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:
Aug/5/2020
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 [BMR2NB]
5.bSample ID [BMR2NC]
5.cSample ID [BP769M]
5.dSample ID [BP769N]
5.eSample ID [BP769P]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040676
Page 12 of 174
***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: 10011135 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/5/2020
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 [BP769F]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040677
Page 13 of 174
***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: 10011135 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/5/2020 16:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040678
Page 14 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040679
Page 15 of 174
***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: 10011135 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/24/2020
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040680
Page 16 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040681
Page 17 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040682
Page 18 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: 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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: EAR
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040683
Page 19 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040684
Page 20 of 174
***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: 10011135 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/24/2020
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 [BP76KZ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040685
Page 21 of 174
***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: 10011135 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/24/2020 15:47
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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040686
Page 22 of 174
***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: 10011135 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/23/2020
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040687
Page 23 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040688
Page 24 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040689
Page 25 of 174
***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: 10011135 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/23/2020
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 [BNW7KW]
5.bSample ID [BNW7L1]
5.cSample ID [BP76RZ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040690
Page 26 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040691
Page 27 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040692
Page 28 of 174
***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: 10011135 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 [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040693
Page 29 of 174
***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: 10011135 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 [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040694
Page 30 of 174
***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: 10011135 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?
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040695
Page 31 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040696
Page 32 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040697
Page 33 of 174
***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: 10011135 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 [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040698
Page 34 of 174
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040699
Page 35 of 174
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040700
Page 36 of 174
***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: 10011135 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/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040701
Page 37 of 174
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040702
Page 38 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040703
Page 39 of 174
***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: 10011135 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 [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040704
Page 40 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EV
ENT 1  Left axilla lymphadeno
pathy Jan/15/2021 UNK:
UNK NO
End Date Time:
Jan/26/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Left arm pain at injecti
on site Jan/15/2021 UNK:
UNK NO
End Date Time:
Feb/16/2021 UNK:UNK
 Repeating
Pages
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040705
Page 41 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left axilla lymphadenopathy]
4.Start Date Time: Jan/15/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040706
Page 42 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040707
Page 43 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left arm pain at injection site]
4.Start Date Time: Jan/15/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/16/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040708
Page 44 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040709
Page 45 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040710
Page 46 of 174
***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: 10011135 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[ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040711
Page 47 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040712
Page 48 of 174
***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: 10011135 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: //
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040713
Page 49 of 174
***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: 10011135 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 Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040714
Page 50 of 174
***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: 10011135 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?
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040715
FDA-CBER-2021-5683-0040716
Page 52 of 174
***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: 10011135 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?
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040717
FDA-CBER-2021-5683-0040718
Page 54 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040719
Page 55 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040720
Page 56 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040721
Page 57 of 174
***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: 10011135 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:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040722
Page 58 of 174
***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: 10011135 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?
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040723
Page 59 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040724
Page 60 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040725
Page 61 of 174
***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: 10011135 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/12/2021
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040726
Page 62 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040727
Page 63 of 174
***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: 10011135 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/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040728
Page 64 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040729
Page 65 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040730
Page 66 of 174
***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: 10011135 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/14/2021
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040731
Page 67 of 174
***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: 10011135 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/14/2021
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040732
Page 68 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040733
Page 69 of 174
***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: 10011135 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/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040734
Page 70 of 174
***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: 10011135 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: Jan/14/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040735
Page 71 of 174
***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: 10011135 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/14/2021
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 [BNW7PC]
5.bSample ID [BNW7PD]
5.cSample ID [BP27CY]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040736
Page 72 of 174
***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: 10011135 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/14/2021
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 [BP27CZ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040737
Page 73 of 174
***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: 10011135 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/14/2021 12:58
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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040738
Page 74 of 174
***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: 10011135 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/19/2021
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040739
Page 75 of 174
***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: 10011135 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: Feb/19/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040740
Page 76 of 174
***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: 10011135 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/19/2021
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 [BP27GW]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040741
Page 77 of 174
***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: 10011135 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/19/2021 11:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040742
Page 78 of 174
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040743
Page 79 of 174
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040744
Page 80 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040745
Page 81 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040746
Page 82 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040747
Page 83 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040748
Page 84 of 174
***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: 10011135 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: [ ]
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040749
Page 85 of 174
***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: 10011135 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/23/2020
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040750
Page 86 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040751
Page 87 of 174
***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: 10011135 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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040752
Page 88 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-05-2020 19:07:09 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)Not Applicable
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040753
Page 89 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-05-2020 19:07:55 (UTC-05:00) Eastern Time
(US & Canada)Sara Hyman
(pfe.shyman)no pertinent medical history
Not Applicable
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040754
Page 90 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-21-2021 12:03:33 (UTC-05:00) Eastern Time
(US & Canada)Nazia Ria
(pfe.nria)Not Applicable
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040755
Page 91 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Nazia Ria  N/A Jan-15-2021 10:22:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan  Approved Oct-11-2020 20:46:27 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkMulligan, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Sara Hyman  N/A Sep-23-2020 14:59:39 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark Mulligan  Approved Sep-15-2020 10:37:41 (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.
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040756
Page 92 of 174
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Aug-05-2020 18:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-05-2020 18:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040757
Page 93 of 174
***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: 10011135 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
Aug-05-2020 18:15:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040758
Page 94 of 174
***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: 10011135 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
Aug-05-2020 18:15:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10011135Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 18:14:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 18:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-05-2020 18:15:23
(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
Aug-05-2020 18:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
WHITEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040759
Page 95 of 174
***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: 10011135 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-05-2020 18:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Aug/5/2020Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040760
Page 96 of 174
***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: 10011135 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
Aug-05-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040761
Page 97 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
56.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-05-2020 19:08:28
(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
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19.8Initial Entry
7.a
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040762
Page 98 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-05-2020 19:08:28
(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
Aug-05-2020 19:08:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040763
Page 99 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-05-2020 19:08:48
(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-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Aug/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-05-2020 19:08:48
(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-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040764
Page 100 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-05-2020 19:08:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040765
Page 101 of 174
***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: 10011135 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
Aug-05-2020 19:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-05-2020 19:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
43218Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040766
Page 102 of 174
***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: 10011135 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-05-2020 18:38:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 18:38:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 18:38:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 18:38:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-05-2020 18:38:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 18:38:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BMR2NBInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040767
Page 103 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 18:38:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BMR2NBInitial Entry
5.b
Date Location User Value Reason
Aug-05-2020 18:38:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BMR2NCInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 18:38:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BMR2NCInitial Entry
5.c
Date Location User Value Reason
Aug-05-2020 18:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BP769MInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 18:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BP769MInitial Entry
5.d
Date Location User Value Reason
Aug-05-2020 18:38:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BP769NInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 18:38:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BP769NInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040768
Page 104 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e
Date Location User Value Reason
Aug-05-2020 18:39:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BP769PInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 18:39:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BP769PInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040769
Page 105 of 174
***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: 10011135 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-05-2020 18:37:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 18:37:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 18:38:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 18:37:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-05-2020 18:37:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 18:38:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
Sample ID: BP769FInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040770
Page 106 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 18:38:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Stephanie
Rettig
(pfe.srettig)Data Entry:
BP769FInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040771
Page 107 of 174
***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: 10011135 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-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-05-2020 19:09:38
(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-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Aug/5/2020 16:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-05-2020 19:09:38
(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-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040772
Page 108 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-05-2020 19:09:38
(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-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-05-2020 19:09:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
YESInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040773
Page 109 of 174
***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: 10011135 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
Aug-05-2020 19:09:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040774
Page 110 of 174
***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: 10011135 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-24-2020 14:32:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040775
Page 111 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040776
Page 112 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)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
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040777
Page 113 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-24-2020 17:09:51
(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 da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040778
Page 114 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-24-2020 17:09:51
(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 com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040779
Page 115 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-24-2020 17:09:51
(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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040780
Page 116 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(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-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-24-2020 17:09:51
(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
Aug-24-2020 17:09:51 ACV0PFEINFP6000  Akeem Data Entry: Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040781
Page 117 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)Moore
(pfe.amoore1)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 17:09:51
(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 the
Subject Diary was complete
d?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040782
Page 118 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 17:09:51
(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-24-2020 17:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040783
Page 119 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 10011135 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-24-2020 17:06:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/24/2020Initial Entry
2.a
Date Location User Value Reason
Aug-24-2020 17:06:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 17:06:07
(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-24-2020 17:06:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-24-2020 17:06:07
(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
Aug-24-2020 17:06:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Akeem
MooreData Entry:
EARInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040784
Page 120 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe.amoore1)
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040785
Page 121 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-24-2020 17:06:21
(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-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 17:06:21
(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-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040786
Page 122 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020 17:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040787
Page 123 of 174
***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: 10011135 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-24-2020 14:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 14:33:28
(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-24-2020 16:17:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 14:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-24-2020 14:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 16:17:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP76KZInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040788
Page 124 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-24-2020 16:17:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
BP76KZInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040789
Page 125 of 174
***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: 10011135 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-24-2020 17:08:27
(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-24-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 17:08:27
(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-24-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
Aug/24/2020 15:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 17:08:27
(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-24-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040790
Page 126 of 174
***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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-24-2020 17:08:27
(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-24-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-24-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Akeem
Moore
(pfe.amoore1)Data Entry:
YESInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040791
Page 127 of 174
***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: 10011135 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-23-2020 14:59:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sep/23/2020Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040792
Page 128 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-23-2020 15:00:52
(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-23-2020 15:00:52
(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-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040793
Page 129 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(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-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(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-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040794
Page 130 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040795
Page 131 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040796
Page 132 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040797
Page 133 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-23-2020 15:00:52
(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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52 ACV0PFEINFP6000  Sara Hyman Data Entry: Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040798
Page 134 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)(pfe.shyman) REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040799
Page 135 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)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
Sep-23-2020 15:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040800
Page 136 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10011135 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
Sep-23-2020 16:34:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 16:34:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 16:35:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 16:34:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-23-2020 16:34:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 16:35:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BNW7KWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040801
Page 137 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-23-2020 16:35:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
BNW7KWInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 16:35:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BNW7L1Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 16:35:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
BNW7L1Initial Entry
5.c
Date Location User Value Reason
Sep-23-2020 16:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sample ID: BP76RZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 16:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
BP76RZInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040802
Page 138 of 174
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 10011135 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
Sep-24-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040803
Page 139 of 174
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Feb-22-2021 13:52:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry: entered in AE log
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Feb/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-22-2021 13:52:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: entered in AE log
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-22-2021 13:52:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-22-2021 13:52:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 13:52:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe nria)Data Entry: entered in AE log
Feb-19-2021 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040804
Page 140 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe nria)Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-22-2021 13:52:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry: entered in AE log
Feb-19-2021 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Left axilla lymphadenopathyInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040805
Page 141 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Nazia Ria
(pfe nria)Form Created
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040806
Page 142 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Nazia Ria
(pfe nria)Form Created
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040807
Page 143 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Left axilla lymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/15/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NO
End Date Time:
Jan/26/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
2Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040808
Page 144 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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).
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-19-2021 14:38:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe nria)Data Entry:
RELATEDentry error
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe nria)Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
Left axilla lymphadenopathyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040809
Page 145 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-19-2021 14:39:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-19-2021 14:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040810
Page 146 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Left arm pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/15/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021
22:27:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by Validation
Check: VC_AE001_10_AN
Feb-22-2021
14:12:02
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Nazia Ria (pfe nria) Query
1: Ans
weredThis data is correct
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040811
Page 147 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Canada)
Feb-20-2021
20:58:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW7331203;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-19-2021
14:35:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe nria) Data
Entry:
NO
End
Date
Time
:
Feb
/16/
202
1 U
NK
:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040812
Page 148 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-19-2021 14:35:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-19-2021 14:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040813
Page 149 of 174
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-27-2021 07:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/12/2021Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040814
Page 150 of 174
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-15-2021 10:22:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination 1
/2Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040815
Page 151 of 174
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-15-2021 10:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-15-2021 10:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040816
Page 152 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-22-2021 01:33:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Jan-21-2021 12:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Query 1: Answered Not Applicable by
selected
Jan-21-2021 02:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Malerato
Moloi
(pfe.moloim)Query 1: Reissued:Opened DM: Since Participant
meets all inclusion
criteria and no
exclusion criteria
.Please consider to
record
Inclusion/Exclusion
Criteria as Not
applicable.
Jan-20-2021 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Query 1: Answered What do you want me
to complete in the
'Inclusion/Exclusion
Criteria'? Please see
the options provided.
Participant meets all
inclusion criteria and
no exclusion criteria.
No options to select
that choice.
Jan-20-2021 12:17:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rajashekhar
Reddy
(pfe.reddyr51)Query 1: Opened DM: Kindly review
and complete
‘Inclusion/Exclusion
Criteria - Further
Vaccination form' at
this visit. Thank you.
Jan-15-2021 10:23:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/14/2021data correction
Jan-15-2021 10:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/15/2021Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040817
Page 153 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:23:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/14/2021Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040818
Page 154 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:23:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-15-2021 10:23:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-15-2021 10:23:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040819
Page 155 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/14/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040820
Page 156 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-15-2021 10:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040821
Page 157 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 10:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 10:24:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 10:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-15-2021 10:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-15-2021 10:24:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Sample ID: BNW7PCInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040822
Page 158 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-15-2021 10:24:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
BNW7PCInitial Entry
5.b
Date Location User Value Reason
Jan-15-2021 10:24:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Sample ID: BNW7PDInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-15-2021 10:24:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
BNW7PDInitial Entry
5.c
Date Location User Value Reason
Jan-15-2021 10:24:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Sample ID: BP27CYInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-15-2021 10:24:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
BP27CYInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040823
Page 159 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:24:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 10:24:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 10:25:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 10:24:51
(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.
Jan-15-2021 10:24:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-15-2021 10:25:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Sample ID: BP27CZInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040824
Page 160 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-15-2021 10:25:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
BP27CZInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040825
Page 161 of 174
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Jan/14/2021 12:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040826
Page 162 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-15-2021 10:26:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YESInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040827
Page 163 of 174
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-23-2021
03:25:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Rose Madelein
(pfe rosem19)Query
1: Clo
sedResponse satisfies query
Feb-23-2021
02:02:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Avinash Gawas
(pfe.gawasa)Query
3: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical Review
Feb-22-2021
22:27:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
2: Clo
sedAuto closed by Validation
Check: VC_SV001_04_AN
Feb-22-2021
14:11:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe.nria) Query
3: Ans
weredThis data is correct
Feb-22-2021
14:11:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe.nria) Query
2: Ans
weredThis data is correct.
Feb-22-2021
13:52:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredAnswer Auto Query
Feb-22-2021
08:36:22
(UTC-05:00)ACV0PFEINFP6000  Malerato Moloi
(pfe moloim)Query
1: Rei
ssued:DM: Thank you, please
note that there cannot be a
date that is after the date of
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040828
Page 164 of 174
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Eastern Time
(US &
Canada)Opene
ddisposition follow-up.
Please update as
appropriate.
Feb-22-2021
01:21:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
3: Op
enedPDQ: Date of visit
V102_VAX4 is out of
window for 13 days from
V101_VAX3 Dose Date.
Please verify and update.
Else, confirm in query
response appropriately.
"[rajkun SDQ=134289]"
Feb-20-2021
20:58:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
2: Op
enedDMW7331186;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-19-2021
15:08:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe.nria) Query
1: Ans
wereddata is correct. Subject still
active in study.
Feb-19-2021
14:29:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Feb-19-2021
12:43:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe.nria) Data
Entry
:
Feb/1
9/202
1Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040829
Page 165 of 174
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-22-2021
22:17:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by Validation
Check: VC_LB001_05_AN
Feb-22-2021
14:11:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe nria) Query
1: Ans
weredThis data is correct
Feb-20-2021
20:32:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW7331090;‘Collection
Date' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition
<- Follow-up> eCRF.
Please clarify or correct.
Feb-19-2021
12:50:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Nazia Ria (pfe nria) Data
Entry:
Feb/19
/2021Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040830
Page 166 of 174
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-19-2021 12:50:12
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040831
Page 167 of 174
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada)
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040832
Page 168 of 174
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Feb-19-2021 12:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021 12:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021 15:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-19-2021 12:43:45
(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.
Feb-19-2021 12:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YES
Date of Collection:
Feb/19/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021 15:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Sample ID: BP27GWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040833
Page 169 of 174
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-19-2021 15:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
BP27GWInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040834
Page 170 of 174
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 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
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
Feb/19/2021 11:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040835
Page 171 of 174
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-19-2021 12:53:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Nazia Ria
(pfe.nria)Data Entry:
YESInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040836
Page 172 of 174
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-22-2021 13:52:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPentered in AE log
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-24-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-05-2020 19:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-05-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-22-2021 13:52:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020entered in AE log
Feb-22-2021 13:52:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020entered in AE log
Feb-19-2021 14:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/5/2021Initial Entry
Sep-24-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
Aug-05-2020 19:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
Aug-05-2020 18:37:40
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040837
Page 173 of 174
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada)
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040838
Page 174 of 174
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1001 Site Name: (1001) NYU Langone Health
Subject No: 10011135 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-11-2020 17:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sara Hyman
(pfe.shyman)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f43\Final\Final On: 01-Apr-2021 03:38 (GMT)
FDA-CBER-2021-5683-0040839