125742 S1 M5 CRF c4591001 1223 12231058

Document text

Page 1 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826952
Page 2 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826953
Page 3 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Demography
1.Subject ID [12231058]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0826954
Page 4 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826955
Page 5 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826956
Page 6 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826957
Page 7 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[diabetes type II]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hypercholesterolemia]
Start Date: Apr/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826958
Page 8 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [74.6]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [27.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826959
Page 9 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826960
Page 10 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [247503]
3.Randomization Group: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826961
Page 11 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPHVJ7]
5.bSample ID [BPHVJ8]
5.cSample ID [BP0XWJ]
5.dSample ID [BP0XWK]
5.eSample ID [BP0XWL]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826962
Page 12 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP0XWH]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826963
Page 13 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: Sep/1/2020 12:47
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826964
Page 14 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826965
Page 15 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826966
Page 16 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826967
Page 17 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826968
Page 18 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826969
Page 19 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826970
Page 20 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BPXXTG]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826971
Page 21 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: Sep/23/2020 12:50
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826972
Page 22 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826973
Page 23 of 225
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?YES
Ongoing?
NO
Stop Date:
Sep/29/2020
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826974
Page 24 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826975
Page 25 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR37X4]
5.bSample ID [BR37X5]
5.cSample ID [BR37X6]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826976
Page 26 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826977
Page 27 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/12/2021
2.Date of First Symptom Started: Feb/3/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [swollen glands]
5.bSymptoms - Other Text: [swollen tonsils]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826978
Page 28 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Feb/3/2021  SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826979
Page 29 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/3/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA CERTIFIED LAB]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826980
Page 30 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [CV46666]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826981
Page 31 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[subject did not come to site to swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826982
Page 32 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826983
Page 33 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Feb/9/2021  NO
Discharge Date:
Feb/12/2021
 Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826984
Page 34 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/9/2021
4.Ongoing? NO
Discharge Date:
Feb/12/2021
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826985
Page 35 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826986
Page 36 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826987
Page 37 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 3
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826988
Page 38 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826989
Page 39 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826990
Page 40 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category for Lab T
estVendor Na
meCollection Dat
e:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Identif
ierTest
:Result
:Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826991
Page 41 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826992
Page 42 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category for Lab
TestVendor Name (DERI
VED)Collection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826993
Page 43 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826994
Page 44 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826995
Page 45 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826996
Page 46 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826997
Page 47 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826998
Page 48 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826999
Page 49 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827000
Page 50 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827001
Page 51 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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.Start Date: //
6.Ongoing?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827002
Page 52 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827003
Page 53 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827004
Page 54 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827005
Page 55 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827006
Page 56 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827007
Page 57 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unplanned Assessments
1.Assessments
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827008
Page 58 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827009
Page 59 of 225
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827010
Page 60 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827011
Page 61 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827012
Page 62 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827013
Page 63 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827014
Page 64 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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:
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827015
Page 65 of 225
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827016
Page 66 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827017
Page 67 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827018
Page 68 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827019
Page 69 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 other protocol allowance(s) and confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827020
Page 70 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827021
Page 71 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/2/2021
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827022
Page 72 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827023
Page 73 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/2/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827024
Page 74 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827025
Page 75 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BR188L]
5.bSample ID [BR188M]
5.cSample ID [BR188N]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827026
Page 76 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BR188K]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827027
Page 77 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: Mar/2/2021 10:50
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827028
Page 78 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/23/2021
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827029
Page 79 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/23/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827030
Page 80 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/23/2021
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 [BRJ4FY]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827031
Page 81 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: Mar/23/2021 10:46
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827032
Page 82 of 225
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827033
Page 83 of 225
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827034
Page 84 of 225
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827035
Page 85 of 225
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827036
Page 86 of 225
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827037
Page 87 of 225
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827038
Page 88 of 225
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827039
Page 89 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#CategoryAE Identifie
rAdverse Event Start DateIs the Adverse Event Still Ongoin
gForm Instance
 1.ADVERSE EVENT
 1  Shortness of breath
 Feb/3/2021 00:00  NO
End Date Time:
Feb/12/2021 UNK:UNK
 Repeating Pages
 2.ADVERSE EVENT
 2  fatigue  Mar/3/2021 09:00
 NO
End Date Time:
Mar/4/2021 09:00
 Repeating Pages
 3.ADVERSE EVENT
 3  injection site pain  Mar/2/2021 15:00
 NO
End Date Time:
Mar/4/2021 09:00
 Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827040
Page 90 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[Shortness of breath]
4.Start Date Time: Feb/3/2021 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown etiology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827041
Page 91 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021156172]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827042
Page 92 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[fatigue]
4.Start Date Time: Mar/3/2021 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 09:00
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
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827043
Page 93 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827044
Page 94 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Mar/2/2021 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 09:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
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
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827045
Page 95 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827046
Page 96 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827047
Page 97 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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[ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827048
Page 98 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Date Form Instance
 1.1  VACCINATIONS  NO  Influenza vaccine
 Oct/12/20
20 Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827049
Page 99 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Influenza vaccine]
5.Date: Oct/12/2020
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827050
Page 100 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827051
Page 101 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827052
Page 102 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827053
Page 103 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827054
Page 104 of 225
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827055
Page 105 of 225
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827056
Page 106 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827057
Page 107 of 225
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827058
Page 108 of 225
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827059
Page 109 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827060
Page 110 of 225
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827061
Page 111 of 225
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan  Approved Mar-24-2021 18:03:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827062
Page 112 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormSep-01-2020 19:25:26 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827063
Page 113 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormMar-04-2021 15:36:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827064
Page 114 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan  Approved Mar-24-2021 18:03:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
Suzana Mutic  N/A Mar-24-2021 15:04:37 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan  Approved Mar-23-2021 18:03:43 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-23-2021 13:52:58 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan  Approved Mar-19-2021 17:27:20 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827065
Page 115 of 225
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Affidavit:
By my dated signature below, I, JessicaTuan, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-15-2021 15:40:17 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Onyema Ogbuagu  Approved Oct-30-2020 14:24:21 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, OnyemaOgbuagu, 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.
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827066
Page 116 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020 19:24:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020 19:24:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827067
Page 117 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 19:24:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/1/2020Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827068
Page 118 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 19:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12231058Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 19:22:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 19:25:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 19:25:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 19:25:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827069
Page 119 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 18:42:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-03-2020 15:27:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered query answered
Sep-02-2020 13:37:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
update Vaccine
Treatment page
Sep-01-2020 19:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827070
Page 120 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020 19:25:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 19:25:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 19:25:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827071
Page 121 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:diabetes type II
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
diabetes type IIInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-01-2020 19:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827072
Page 122 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Medical History Te
rm:hypercholesterole
mia
Start Date: Apr/UNK/2020
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 19:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 19:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 19:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 19:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-01-2020 19:28:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:depression
Start Date: UNK/UNK/198
0
Ongoing: YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827073
Page 123 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020 19:28:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 19:28:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 19:28:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020 19:28:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827074
Page 124 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
74.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.4Initial Entry
7.a
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827075
Page 125 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.2
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 19:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827076
Page 126 of 225
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827077
Page 127 of 225
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-01-2020 19:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827078
Page 128 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
247503Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827079
Page 129 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 19:34:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 19:34:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 17:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-03-2020 17:26:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-03-2020 17:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 01:58:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-01-2020 19:34:12
(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-01-2020 19:34:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827080
Page 130 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a
Date Location User Value Reason
Sep-03-2020 17:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHVJ7Transcription Error
(DELETED)
Sep-03-2020 17:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHVJ7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 17:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHVJ7Transcription Error
(DELETED)
Sep-03-2020 17:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHVJ7Initial Entry
5.b
Date Location User Value Reason
Sep-03-2020 17:26:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHVJ8Transcription Error
(DELETED)
Sep-03-2020 17:10:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHVJ8Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 17:26:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHVJ8Transcription Error
(DELETED)
Sep-03-2020 17:10:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHVJ8Initial Entry
5.c
Date Location User Value Reason
Sep-03-2020 17:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0XWJInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827081
Page 131 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 17:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP0XWJInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020 17:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0XWKInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 17:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP0XWKInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020 17:26:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0XWLInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 17:26:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP0XWLInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827082
Page 132 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 19:34:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 19:34:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 17:11:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 01:59:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-01-2020 19:34:24
(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-01-2020 19:34:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 17:11:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0XWHInitial Entry
5.a Sample ID
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827083
Page 133 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Sep-03-2020 17:11:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP0XWHInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827084
Page 134 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 12:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827085
Page 135 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-03-2020 15:08:53
(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
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-03-2020 15:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827086
Page 136 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020 16:39:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTNew Information
Sep-01-2020 19:34:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827087
Page 137 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827088
Page 138 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827089
Page 139 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.b Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827090
Page 140 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827091
Page 141 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827092
Page 142 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.h
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-29-2020 15:44:45
(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-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827093
Page 143 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
S
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827094
Page 144 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 15:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827095
Page 145 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.7
Temperature Unit: F
Temperature Location:
:FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827096
Page 146 of 225
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827097
Page 147 of 225
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020 16:31:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827098
Page 148 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 16:31:54
(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 16:31:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 11:23:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 05:31:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-23-2020 16:31:54
(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 16:31:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 11:23:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXTGInitial Entry
5.a Sample ID
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827099
Page 149 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Sep-24-2020 11:23:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXTGInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827100
Page 150 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827101
Page 151 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-23-2020 16:32:43
(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
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-23-2020 16:32:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827102
Page 152 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 11:29:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827103
Page 153 of 225
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-28-2020 18:39:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUENew Information
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827104
Page 154 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:YES
Ongoing
?
NO
Stop
Date:
Sep/
29/2
020
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:YE
SInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827105
Page 155 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.b Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-29-2020 07:55:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-28-2020 18:39:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020 18:39:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/29/2020New Information
Oct-26-2020 04:40:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: If yes, please
update end date or
ongoing details. Thank
you.
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
2.c
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827106
Page 156 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.c Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NGInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827107
Page 157 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.e Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-23-2020 16:29:39 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827108
Page 158 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern Time
(US & Canada)Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.g Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827109
Page 159 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.h Symptom:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-23-2020 16:29:39
(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
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827110
Page 160 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827111
Page 161 of 225
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-23-2020 16:29:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827112
Page 162 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 11:29:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:29:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 10:44:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-23-2020 02:12:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-22-2020 11:29:54
(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.
Oct-22-2020 11:29:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 10:44:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37X4Initial Entry
5.a Sample ID
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827113
Page 163 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Oct-23-2020 10:44:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR37X4Initial Entry
5.b
Date Location User Value Reason
Oct-23-2020 10:44:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37X5Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 10:44:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR37X5Initial Entry
5.c
Date Location User Value Reason
Oct-23-2020 10:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37X6Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 10:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR37X6Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827114
Page 164 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 15:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-15-2021 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Feb-15-2021 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Feb-15-2021 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-15-2021 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827115
Page 165 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-18-2021 14:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Jessica Tuan Data Entry:
Feb/3/2021Changed Information
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-12-2021 08:54:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-11-2021 16:52:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Jessica Tuan Query 1: Answered Called subject today
and symptoms are still
ongoing.
Mar-11-2021 15:49:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: As subject was
recently vaccinated on
02Mar2021, please
clarify whether the
reported symptoms are
still ongoing. If
symptoms have ended,
please update
‘Symptoms Ongoing’
to ‘NO’ and add Date
of Last Symptom
Resolved on the CRF.
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827116
Page 166 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-15-2021 15:41:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present:Initial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-15-2021 15:41:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pr
esent:NOInitial Entry
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pr
esent:Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827117
Page 167 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.b Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827118
Page 168 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.d Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom Pr
esent:NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827119
Page 169 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.f Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE THROA
TInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827120
Page 170 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.h Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-15-2021 15:41:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-15-2021 15:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: swollen glandsInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-15-2021 15:42:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
swollen glandsInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827121
Page 171 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US & Canada)
5.b
Date Location User Value Reason
Feb-15-2021 15:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: swollen tonsilsInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-15-2021 15:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
swollen tonsilsInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827122
Page 172 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827123
Page 173 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME C
ORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827124
Page 174 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-15-2021 15:43:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-18-2021
00:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-17-2021
15:29:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edChanged
Information
Feb-17-2021
15:29:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CLIA CERTIFIE
D LABChanged
Information
Feb-17-2021
03:18:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Opened Trade name
Manufacturer
name provided as"
CVS PCR" does
not uniquely
match with the
FDA List. Kindly
update data as
requested else
please confirm
and add text
"CLIA certified
lab", Thank you.
Feb-15-2021
15:43:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CVS PCRInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827125
Page 175 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-15-2021 15:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021 15:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 10:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-17-2021 08:22:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-15-2021 15:43:45
(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-15-2021 15:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021 10:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
Sample ID: CV46666Initial Entry
5.a Sample ID
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827126
Page 176 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-17-2021 10:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
CV46666Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827127
Page 177 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-15-2021 15:44:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021 15:44:10
(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-15-2021 15:44:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-15-2021 15:44:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
subject did not come to site to swabInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827128
Page 178 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIALI
ST
Occurrence of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGENCY R
OOM
Occurrence of Visi
ts or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827129
Page 179 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:PRIMARY CARE
PHYSICIAN
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.d
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827130
Page 180 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT C
ARE
Occurrence of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:TELEPHONE CO
NSULTATION
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-15-2021 15:45:09 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827131
Page 181 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern Time
(US & Canada)Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:NO
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:Initial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-15-2021 15:45:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-15-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive care
due to potential COVID-19 illness?
NOInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827132
Page 182 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-15-2021 15:45:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827133
Page 183 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-15-2021 15:45:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-15-2021 15:45:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-05-2021 13:42:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Follow up with CRA
offline.
Mar-05-2021 12:57:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered hospital records are
pending.
Mar-02-2021 14:54:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY: As subject
was confirmed
hospitalized please
enter any available
information (vital signs,
pulse oxymet,
respiratory treatment,
lab results, imaging…).
Please make every
effort to obtain these
information.
Mar-02-2021 14:11:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Jessica Tuan Query 1: Answered Yes she was
hospitalized.
Feb-23-2021 15:08:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY: Please
confirm if subject was
hospitalized due to
COV ILL? if so please
complete any of the
assessment CRF's
within this visit.
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827134
Page 184 of 225
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-23-2021 15:01:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Jessica Tuan Query 1: Answered Original value is correct
Feb-16-2021 11:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Hospitalization: This
subject had COVID-19
Illness and was
hospitalized. Please
enter any available
information (vital signs,
pulse oxymet,
respiratory treatment,
lab results, imaging…).
Please make every
effort to obtain these
information.
Feb-15-2021 15:45:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-15-2021 15:48:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Feb/12/2021New Information
Feb-15-2021 15:45:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827135
Page 185 of 225
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/12/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-15-2021 15:47:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-15-2021 15:47:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-15-2021 15:47:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827136
Page 186 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 11:31:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 11:31:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 11:31:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827137
Page 187 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 15:24:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827138
Page 188 of 225
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021 18:11:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 15:25:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-23-2021 15:25:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible per other protocol allowance
(s) and confirmed to have received o
nly placebo at Vaccination 1/2Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827139
Page 189 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 15:36:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827140
Page 190 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-04-2021 15:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Mar/2/2021Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827141
Page 191 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-04-2021 15:36:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 15:36:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 15:36:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827142
Page 192 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827143
Page 193 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
6.a Sponsor ID:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Mar-04-2021 15:37:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827144
Page 194 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021 15:37:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021 15:37:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021 13:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-05-2021 05:17:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Mar-04-2021 15:37:47
(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.
Mar-04-2021 15:37:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021 13:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR188LInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827145
Page 195 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a Sample ID
Date Location User Value Reason
Mar-05-2021 13:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR188LInitial Entry
5.b
Date Location User Value Reason
Mar-05-2021 13:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR188MInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-05-2021 13:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR188MInitial Entry
5.c
Date Location User Value Reason
Mar-05-2021 13:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR188NInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-05-2021 13:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR188NInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827146
Page 196 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021 15:38:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021 15:38:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021 11:43:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-05-2021 05:17:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Mar-04-2021 15:38:02
(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.
Mar-04-2021 15:38:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021 11:43:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR188KInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827147
Page 197 of 225
***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, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a Sample ID
Date Location User Value Reason
Mar-05-2021 11:43:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR188KInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827148
Page 198 of 225
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021 10:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827149
Page 199 of 225
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-04-2021 15:38:42
(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
Mar-04-2021 15:38:42
(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
Mar-04-2021 15:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827150
Page 200 of 225
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-23-2021 13:52:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/23/2021Initial Entry
090177e196ae3015\Final\Final On: 01-Apr-2021 03:59 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827151
Page 201 of 225
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-23-2021 13:53:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-23-2
…[truncated]