125742 S1 M5 CRF c4591001 1169 11691010

Document text

Page 1 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814882
Page 2 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814883
Page 3 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11691010]
2.Birth Date: /1990
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:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814884
Page 4 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814885
Page 5 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814886
Page 6 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814887
Page 7 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Apr/20/2018
Ongoing: YES
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814888
Page 8 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [222.5]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [30.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814889
Page 9 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/3/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814890
Page 10 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [76419]
3.Randomization Group: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814891
Page 11 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BP0T1S]
5.bSample ID [BPHF57]
5.cSample ID [BPHF58]
5.dSample ID [BPHF59]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814892
Page 12 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BP0T1P]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814893
Page 13 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/3/2020 12:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814894
Page 14 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814895
Page 15 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814896
Page 16 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814897
Page 17 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814898
Page 18 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP0T6C]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814899
Page 19 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/25/2020 10:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814900
Page 20 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814901
Page 21 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BP0T91]
5.bSample ID [BPHFF6]
5.cSample ID [BPHFF7]
5.dSample ID [BPHFF8]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814902
Page 22 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814903
Page 23 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814904
Page 24 of 149
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814905
Page 25 of 149
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814906
Page 26 of 149
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814907
Page 27 of 149
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814908
Page 28 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814909
Page 29 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814910
Page 30 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814911
Page 31 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814912
Page 32 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814913
Page 33 of 149
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814914
Page 34 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814915
Page 35 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814916
Page 36 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814917
Page 37 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814918
Page 38 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814919
Page 39 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814920
Page 40 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814921
Page 41 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814922
Page 42 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Swollen Right Axil
lary lymph node Sep/3/202
0 13:00 NO
End Date Time:
Oct/12/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Injection Site pain  Sep/25/20
20 10:30 NO
End Date Time:
Sep/26/2020 UN
K:UNK
 Repeating
Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814923
Page 43 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Swollen Right Axillary lymph node]
4.Start Date Time: Sep/3/2020 13:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814924
Page 44 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814925
Page 45 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814926
Page 46 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Injection Site pain]
4.Start Date Time: Sep/25/2020 10:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/26/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814927
Page 47 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814928
Page 48 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814929
Page 49 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814930
Page 50 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814931
Page 51 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned Identifie
rCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of Med
icationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Seasonal Influ
enza Vaccine Oct/16
/2020 Repeating
Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814932
Page 52 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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).[Seasonal Influenza Vaccine]
5.Date: Oct/16/2020
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814933
Page 53 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814934
Page 54 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814935
Page 55 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814936
Page 56 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814937
Page 57 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814938
Page 58 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814939
Page 59 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814940
Page 60 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814941
Page 61 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814942
Page 62 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814943
Page 63 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814944
Page 64 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814945
Page 65 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814946
Page 66 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814947
Page 67 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814948
Page 68 of 149
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814949
Page 69 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814950
Page 70 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814951
Page 71 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814952
Page 72 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814953
Page 73 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814954
Page 74 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814955
Page 75 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814956
Page 76 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814957
Page 77 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-03-2020 14:17:32 (UTC-05:00)
Eastern Time (US & Canada)Subject meets all inclusion criteria
and no exclusion criteria
Not Applicable
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814958
Page 78 of 149
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-11-2021 14:49:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Nov-03-2020 13:28:47 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JosephYozviak, 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.
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814959
Page 79 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020
14:16:19
(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-03-2020
14:16:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814960
Page 80 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020
14:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/3/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814961
Page 81 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020
14:16:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11691010Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020
14:16:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020
14:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814962
Page 82 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-03-2020
14:16:47
(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-03-2020
14:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814963
Page 83 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814964
Page 84 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020
14:17:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020
14:17:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020
14:17:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814965
Page 85 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020
14:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Anxiet
y
Start Date: Apr/20/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020
14:25:54
(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-03-2020
14:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814966
Page 86 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.a Start Date:
Date Location User Value Reason
Sep-03-2020
14:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Apr/20/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020
14:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814967
Page 87 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
222.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814968
Page 88 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.2Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814969
Page 89 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814970
Page 90 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020
14:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814971
Page 91 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020
14:20:28
(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-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814972
Page 92 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-03-2020
14:20:28
(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-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814973
Page 93 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814974
Page 94 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020
14:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020
14:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
76419Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814975
Page 95 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
16:27:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
16:27:52
(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
16:28:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
16:27:52
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814976
Page 96 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
16:27:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
16:28:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0T1
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
16:28:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T1SInitial Entry
5.b
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814977
Page 97 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-03-2020
16:28:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF5
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
16:28:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF57Initial Entry
5.c
Date Location User Value Reason
Sep-03-2020
16:28:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF5
8Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814978
Page 98 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
16:28:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF58Initial Entry
5.d
Date Location User Value Reason
Sep-03-2020
16:29:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF5
9Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020
16:29:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF59Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814979
Page 99 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
16:29:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
16:29:49
(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
16:30:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
16:29:49
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814980
Page 100 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
16:29:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
16:30:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0T1
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
16:30:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T1PInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814981
Page 101 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020
14:22:49
(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
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814982
Page 102 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-03-2020
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020 12:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020
14:22:49
(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
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814983
Page 103 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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
14:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814984
Page 104 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020
14:23:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814985
Page 105 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
10:17:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814986
Page 106 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.1
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814987
Page 107 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
10:17:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814988
Page 108 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
10:18:01
(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-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814989
Page 109 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-25-2020
10:18:01
(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-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814990
Page 110 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020
10:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814991
Page 111 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
13:10:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
13:10:53
(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-25-2020
13:11:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
13:10:53
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814992
Page 112 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
13:10:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
13:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0T6
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
13:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T6CInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814993
Page 113 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814994
Page 114 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 10:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
10:18:32
(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-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814995
Page 115 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-25-2020
10:18:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814996
Page 116 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020
10:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-30-2020
12:59:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Oct-30-2020
04:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814997
Page 117 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
EOT to match
date of blood
sample
collection date
at visit 3.
Oct-26-2020
13:36:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(
 
 
 
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814998
Page 118 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020
13:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020
13:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020
13:59:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-26-2020
13:57:59
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814999
Page 119 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-26-2020
13:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020
13:59:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP0T9
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020
13:59:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T91Initial Entry
5.b
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815000
Page 120 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-26-2020
13:59:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHFF
6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020
13:59:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFF6Initial Entry
5.c
Date Location User Value Reason
Oct-26-2020
13:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHFF
7Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815001
Page 121 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Oct-26-2020
13:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFF7Initial Entry
5.d
Date Location User Value Reason
Oct-26-2020
14:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHFF
8Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-26-2020
14:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFF8Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815002
Page 122 of 149
***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: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
12:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
12:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
12:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815003
Page 123 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815004
Page 124 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815005
Page 125 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020
16:41:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clos
edResponse satisfies
query
Oct-27-2020
16:12:03
(UTC-05:00)ACV0PFEINFP6000  Query 2: Ans
weredAs per PI, subject did
not meet delay criteria
due to the AE of
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815006
Page 126 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)swollen right axillary
lymph node.
Oct-26-2020
18:30:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Open
edClinQuery: Please
confirm the subject did
not meet TDV criteria
at V2 listed in protocol
section 5.5 as a result
of Swollen Right
Axillary Lymph Node
from
03Sep2020-12Oct2020.
Thanks.
Oct-26-2020
18:30:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edcreated in error
Oct-26-2020
18:29:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Open
edClinQuery: Please
confirm the subject did
not meet TDV criteria
at V2 listed in protocol
section 5.5 as a result
of Swollen Right
Axillary Lymph Node
from 03Sep2020-
ongoing. Thanks.
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Swollen Right
Axillary lymp
h nodeInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815007
Page 127 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4. Start Date Time:
Date Location User Value Reason
Sep-28-2020
09:27:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Sep-28-2020
09:18:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered AE remains
ongoing,
assessed on 25
September
2020.
Sep-25-2020
16:58:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery:
Please verify if
Swollen right
Axillary
Lymph Node is
truly ongoing,
then update the
END DATE
and
OUTCOME as
appropriate.
Sep-23-2020
15:10:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-23-2020
15:10:34ACV0PFEINFP6000  Data Entry:
Sep/3/2020 13:00New
Information
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815008
Page 128 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Swollen Right
Axillary lymph
node: Start
Date is the
same as a
Vaccination
Date, but time
is not
provided.
Please review
and update as
appropriate.
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-22-2020
14:05:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Oct-22-2020
13:04:05ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answer
edNew
Information
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815009
Page 129 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)
Oct-22-2020
13:04:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/12/2020
UNK:UNKNew
Information
Oct-16-2020
17:01:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery:
Please verify
if Swollen
Right Axillary
Lymph Node
is ongoing,
then update
the END
DATE and
OUTCOME
as appropriate.
Oct-06-2020
12:59:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-05-2020
15:14:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edCalled subject
today, lymph
node is still
swollen, but
has reduced in
size. Ae
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815010
Page 130 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
remains open
Oct-02-2020
15:17:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please verify
if Swollen
right Axillary
Lymph Node
is truly
ongoing, then
update the
END DATE
and
OUTCOME
as appropriate.
Oct-02-2020
15:00:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Candid
ateClinQuery:
Please verify
if Swollen
right Axillary
Lymph Node
is truly
ongoing, then
update the
END DATE
and
OUTCOME
as appropriate.
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815011
Page 131 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815012
Page 132 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020
15:08:01ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815013
Page 133 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020
09:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-26-2020
09:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDNew
Information
Oct-22-2020
13:04:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Swollen
Right Axillary
lymph node:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
Sep-23-2020
15:08:01ACV0PFEINFP6000  Data Entry:
NOT RECOVEREInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815014
Page 134 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)D/NOT RESOLVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020
15:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815015
Page 135 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site painInitial Entry
4. Start Date Time:
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815016
Page 136 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 10:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/26/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815017
Page 137 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815018
Page 138 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815019
Page 139 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020
13:39:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815020
Page 140 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815021
Page 141 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815022
Page 142 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Seasonal Influenza V
accineInitial Entry
5. Date:
Date Location User Value Reason
Oct-26-2020
13:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815023
Page 143 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
14:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815024
Page 144 of 149
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021
10:43:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-12-2021
01:03:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-11-2021
14:49:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815025
Page 145 of 149
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
complete this
date.
Feb-11-2021
14:49:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have received
only placebo at
Vaccination 1/2Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815026
Page 146 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
10:43:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
10:43:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815027
Page 147 of 149
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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1. Subject Status
Date Location User Value Reason
Oct-30-2020
12:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020
14:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-03-2020
14:17:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
12:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Sep-03-2020
14:23:34ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815028
Page 148 of 149
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-03-2020
14:17:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815029
Page 149 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
10:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae30ea\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815030