125742 S1 M5 CRF c4591001 1169 11691056

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
305
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 305
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815191
Page 2 of 305
***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: 11691056 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/16/2020
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815192
Page 3 of 305
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11691056]
2.Birth Date: /1984
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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815193
Page 4 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815194
Page 5 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815195
Page 6 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815196
Page 7 of 305
***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: 11691056 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:[Gastro esophageal reflux disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[polycystic ovarian syndrome]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[asthma]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815197
Page 8 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Essential Hypertension]
Start Date: Aug/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[anxiety]
Start Date: Apr/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Urinary tract infection]
Start Date: Sep/13/2020
Ongoing: YES
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815198
Page 9 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vitamin D Deficiency]
Start Date: Mar/UNK/2019
Ongoing: YES
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815199
Page 10 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [107.5]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [37.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815200
Page 11 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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/16/2020
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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815201
Page 12 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [91124]
3.Randomization Group: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815202
Page 13 of 305
***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: 11691056 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/16/2020
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 [BP0T4K]
5.bSample ID [BPHF9V]
5.cSample ID [BPHF9W]
5.dSample ID [BPHF9X]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815203
Page 14 of 305
***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: 11691056 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/16/2020
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 [BP0T3S]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815204
Page 15 of 305
***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: 11691056 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/16/2020 12:16
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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815205
Page 16 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815206
Page 17 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815207
Page 18 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815208
Page 19 of 305
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: Oct/8/2020
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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815209
Page 20 of 305
***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: 11691056 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:
Oct/8/2020
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 [BP0T82]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815210
Page 21 of 305
***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: 11691056 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: Oct/8/2020 09:24
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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815211
Page 22 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815212
Page 23 of 305
***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: 11691056 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:
Nov/9/2020
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 [BP0TBV]
5.bSample ID [BPHFL7]
5.cSample ID [BPHFL8]
5.dSample ID [BPHFL9]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815213
Page 24 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815214
Page 25 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815215
Page 26 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815216
Page 27 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815217
Page 28 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815218
Page 29 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815219
Page 30 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815220
Page 31 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/24/2020
2.Date of First Symptom
Started:Nov/23/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815221
Page 32 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Fatigue]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815222
Page 33 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Nov/24/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815223
Page 34 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/24/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [Clia Certified lab]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815224
Page 35 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/24/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW85915]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815225
Page 36 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Subject did a self swab at home.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815226
Page 37 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815227
Page 38 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815228
Page 39 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815229
Page 40 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815230
Page 41 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815231
Page 42 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815232
Page 43 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815233
Page 44 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815234
Page 45 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815235
Page 46 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815236
Page 47 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815237
Page 48 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815238
Page 49 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815239
Page 50 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815240
Page 51 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815241
Page 52 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815242
Page 53 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815243
Page 54 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815244
Page 55 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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.Start Date: //
6.Ongoing?
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815245
Page 56 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815246
Page 57 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815247
Page 58 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815248
Page 59 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:
Dec/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0TCC]
5.bSample ID [BPHFMR]
5.cSample ID [BPHFMS]
5.dSample ID [BPHFMT]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815249
Page 60 of 305
***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: 11691056 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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815250
Page 61 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815251
Page 62 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815252
Page 63 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815253
Page 64 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yAE I
dentif
ierAdverse EventStart Dat
eIs the Adverse
Event Still Ong
oingForm Insta
nce
 1. ADVER
SE EVE
NT 1 Fatigue  Oct/9/202
0 01:30 NO
End Date Time
:
Oct/9/2020 0
6:00
 Repeating
Pages
 2. DELETED ADVER
SE EVE
NT 2 Fever  Oct/9/202
0 01:30 NO
End Date Time
:
Oct/9/2020 0
6:00
 Repeating
Pages
 3. ADVER
SE EVE
NT 3 Fever of 99.9  Oct/8/202
0 21:00 NO
End Date Time
:
Oct/9/2020 0
0:00
 Repeating
Pages
 4. ADVER
SE EVE
NT 4 Pain at injection
Site Oct/8/202
0 21:00 NO
End Date Time
:
Oct/11/2020
UNK:UNK
 Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815254
Page 65 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yAE I
dentif
ierAdverse EventStart Dat
eIs the Adverse
Event Still Ong
oingForm Insta
nce
 5. ADVER
SE EVE
NT 5 Toenail Onychol
ysis x3 Dec/14/20
20 UNK:
UNK NO
End Date Time
:
Jan/15/2021
UNK:UNK
 Repeating
Pages
 6. ADVER
SE EVE
NT 6 Enlarged Bilater
al Inguinal Lym
ph Nodes Dec/16/20
20 UNK:
UNK NO
End Date Time
:
Jan/6/2021 U
NK:UNK
 Repeating
Pages
 7. ADVER
SE EVE
NT 7 Bilateral Lower
extremity swelli
ng Dec/16/20
20 UNK:
UNK NO
End Date Time
:
Feb/16/2021
UNK:UNK
 Repeating
Pages
 8. ADVER
SE EVE
NT 8 Tremors  Dec/31/20
20 UNK:
UNK YES  Repeating
Pages
 9. ADVER
SE EVE
NT 9 Tachycardia  Dec/31/20
20 UNK:
UNK YES  Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815255
Page 66 of 305
***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: 11691056 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)[Fatigue]
4.Start Date Time: Oct/9/2020 01:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 06:00
6.Toxicity Grade: 1
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815256
Page 67 of 305
***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: 11691056 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?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815257
Page 68 of 305
***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: 11691056 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[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815258
Page 69 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fever]
4.Start Date Time: Oct/9/2020 01:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 06:00
6.Toxicity Grade: 1
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815259
Page 70 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815260
Page 71 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815261
Page 72 of 305
***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: 11691056 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fever of 99.9]
4.Start Date Time: Oct/8/2020 21:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 00:00
6.Toxicity Grade: 1
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815262
Page 73 of 305
***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: 11691056 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?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815263
Page 74 of 305
***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: 11691056 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[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815264
Page 75 of 305
***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: 11691056 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at injection Site]
4.Start Date Time: Oct/8/2020 21:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/11/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815265
Page 76 of 305
***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: 11691056 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?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815266
Page 77 of 305
***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: 11691056 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[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815267
Page 78 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Toenail Onycholysis x3]
4.Start Date Time: Dec/14/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815268
Page 79 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown Cause]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815269
Page 80 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815270
Page 81 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Enlarged Bilateral Inguinal Lymph Nodes]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/6/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815271
Page 82 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown cause]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815272
Page 83 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815273
Page 84 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Bilateral Lower extremity swelling]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/16/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815274
Page 85 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown cause at this time]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815275
Page 86 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815276
Page 87 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Tremors]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815277
Page 88 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Cause Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815278
Page 89 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815279
Page 90 of 305
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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: [9]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Tachycardia]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815280
Page 91 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Cause unknown at this time]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815281
Page 92 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815282
Page 93 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815283
Page 94 of 305
***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: 11691056 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[ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815284
Page 95 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of Med
icationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Seasonal Influ
enza vaccine Oct/30
/2020 Repeating
Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815285
Page 96 of 305
***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: 11691056 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/30/2020
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815286
Page 97 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815287
Page 98 of 305
***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: 11691056 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?
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815288
Page 99 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815289
Page 100 of 305
***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: 11691056 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?
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815290
Page 101 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815291
Page 102 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815292
Page 103 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815293
Page 104 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815294
Page 105 of 305
***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: 11691056 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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815295
Page 106 of 305
***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: 11691056 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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815296
Page 107 of 305
***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: 11691056 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?
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815297
Page 108 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815298
Page 109 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815299
Page 110 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815300
Page 111 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815301
Page 112 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815302
Page 113 of 305
***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: 11691056 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 [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815303
Page 114 of 305
***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: 11691056 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: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815304
Page 115 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815305
Page 116 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815306
Page 117 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815307
Page 118 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815308
Page 119 of 305
***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: 11691056 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: [ ]
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815309
Page 120 of 305
***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: 11691056 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 Nov/9/2020
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815310
Page 121 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815311
Page 122 of 305
***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: 11691056 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
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815312
Page 123 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-16-2020 11:52:16 (UTC-05:00)
Eastern Time (US & Canada)Meets all criteria
Not Applicable
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815313
Page 124 of 305
***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: 11691056 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-04-2021 12:33:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Jan-25-2021 07:33:53 (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.
 N/A Dec-15-2020 13:38:59 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815314
Page 125 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
N/A
Joseph
Yozviak Approved Dec-02-2020 06:55:05 (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.
 N/A Nov-30-2020 11:45:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Nov-30-2020 10:37:46 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815315
Page 126 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.
 N/A Nov-27-2020 13:27:21 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Nov-25-2020 09:13:57 (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.
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815316
Page 127 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
 N/A Nov-24-2020 15:02:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Nov-11-2020 14:19:03 (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.
 N/A Nov-10-2020 11:35:00 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Joseph
Yozviak Approved Nov-10-2020 11:02:24 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815317
Page 128 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815318
Page 129 of 305
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 11691056 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-16-2020
11:50:20
(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-16-2020
11:50:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815319
Page 130 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020
11:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/16/2020Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815320
Page 131 of 305
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020
11:50:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11691056Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020
11:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1984Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020
11:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815321
Page 132 of 305
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
11:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020
11:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815322
Page 133 of 305
***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: 11691056 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-16-2020
11:52:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815323
Page 134 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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-16-2020
11:52:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020
11:52:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020
11:52:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815324
Page 135 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020
14:24:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/M
H Num
ber:1
Medical
History
Term:Gastro eso
phageal re
flux diseas
e
Start D
ate:UNK/UN
K/2015
Ongoin
g:YESChanged
Information
Sep-16-2020
14:06:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/M
H Num
ber:1
Medical
History
Term:Gastro eso
phageal re
flux diseas
e
Start D
ate:UNK/UN
K/2020
Ongoin
g:YESChanged
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815325
Page 136 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
14:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medical
History
Term:Gastro eso
phageal re
flux diseas
e
Start D
ate:Sep/16/20
20
Ongoin
g:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:05:04
(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-16-2020
14:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Gastro esophageal ref
lux diseaseInitial Entry
1.a Start Date:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815326
Page 137 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-16-2020
14:24:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
14:24:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2015Changed
Information
Sep-16-2020
14:06:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2020Changed
Information
Sep-16-2020
14:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 16/Sep
/2020. Please
review and
update as
appropriate.
Sep-16-2020
14:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/16/2020Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815327
Page 138 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020
14:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-16-2020
14:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/M
H Numb
er:2
Medical
History
Term:polycystic
ovarian sy
ndrome
Start Da
te:UNK/UN
K/2000
Ongoing
:YESNew
Information
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:polycystic
ovarian sy
ndromeInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815328
Page 139 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Da
te:UNK/UN
K/2020
Ongoing
:YES
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815329
Page 140 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
polycystic ovarian sy
ndromeInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020
14:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
14:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2000New
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815330
Page 141 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 16/Sep
/2020. Please
review and
update as
appropriate.
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020
14:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-16-2020
14:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/MH
Number:3New
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815331
Page 142 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical H
istory Ter
m:asthma
Start Date
:UNK/U
NK/201
5
Ongoing: YES
Sep-16-2020
14:10:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/MH
Number:3
Medical H
istory Ter
m:asthma
Start Date
:UNK/U
NK/202
0
Ongoing: YESInitial Entry
Sep-16-2020
14:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:asthma
Start Date
:UNK/U
NK/202
0
Ongoing:Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815332
Page 143 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
asthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020
14:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
14:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2015New
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815333
Page 144 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
14:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 16/Sep
/2020. Please
review and
update as
appropriate.
Sep-16-2020
14:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020
14:10:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-16-2020
14:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/MH
Number:4New
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815334
Page 145 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical
History T
erm:Essential
Hyperten
sion
Start Dat
e:Aug/UN
K/2018
Ongoing: YES
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Essential
Hyperten
sion
Start Dat
e:UNK/U
NK/2020
Ongoing: YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815335
Page 146 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Essential Hypertensio
nInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020
14:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
14:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Aug/UNK/2018New
Information
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815336
Page 147 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 16/Sep
/2020. Please
review and
update as
appropriate.
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020
14:12:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-16-2020
14:28:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Line/MH N
umber:5
Medical Hi
story Term:anxietyInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815337
Page 148 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: Apr/UN
K/2018
Ongoing: YES
Sep-16-2020
14:28:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:anxiety
Start Date: Apr/UN
K/2018
Ongoing:Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815338
Page 149 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:28:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:28:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
anxietyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020
14:28:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Apr/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020
14:28:54ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815339
Page 150 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-16-2020
14:31:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:seasonal
allergies
Start Date: UNK/U
NK/2012
Ongoing: YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815340
Page 151 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:31:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:31:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
seasonal allergiesInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-16-2020
14:31:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-16-2020
14:31:26ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815341
Page 152 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815342
Page 153 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.g
Date Location User Value Reason
Sep-16-2020
14:32:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:Urinary tr
act infecti
on
Start Date
:Sep/13/20
20
Ongoing: YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815343
Page 154 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:32:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
14:28:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Sep-18-2020
11:03:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesQuery 1: Answered Patient was
current with
antibiotic
treatments for
the UTI , not
symptomatic at
the time of
visit an INC #
3 and Exc # 1 ,
did not prevent
her from study
Sep-17-2020
17:41:26
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: This
is a condition
with an onset
just 3 days
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815344
Page 155 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) prior to 1st
dose. Please
clarify if the
subject was on
treatment for
UTI and if it
was
symptomatic at
enrollment.
What's PI's
assessment
against
Inclusion #3
and Ex #1.
Sep-16-2020
14:32:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Urinary tract infecti
onInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-16-2020
14:32:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/13/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815345
Page 156 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
14:32:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-16-2020
14:33:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:vitamin D
Deficienc
y
Start Date
:Mar/UNK
/2019
Ongoing: YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815346
Page 157 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.h Line/MH Number:
Date Location User Value Reason
Sep-16-2020
14:33:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
14:33:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
vitamin D DeficiencyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-16-2020
14:33:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Mar/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-16-2020
14:33:25ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815347
Page 158 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815348
Page 159 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
107.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815349
Page 160 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.6Initial Entry
7.a
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Record Ide
ntifier::1
Temperatu
re:98.8Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815350
Page 161 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
FInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815351
Page 162 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
13:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
ORAL CAVITYInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815352
Page 163 of 305
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020
13:51:47
(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-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815353
Page 164 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
13:51:47
(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-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020
13:51:47
(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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815354
Page 165 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020
13:51:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
NEGATIVEInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815355
Page 166 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020
12:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020
12:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
91124Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815356
Page 167 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
12:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
12:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
12:37:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
12:36:16
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815357
Page 168 of 305
***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: 11691056 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-16-2020
12:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
12:37:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP0T4
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
12:37:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T4KInitial Entry
5.b
090177e196ae30e9\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-2021-5683-0815358
Page 169 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-16-2020
12:37:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHF9
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-16-2020
12:37:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF9VInitial Entry
5.c
Date Location User Value Reason
Sep-16-2020
12:38:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF9
WInitial Entry
090177e196ae30e9\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-2021-5683-0815359
Page 170 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Sep-16-2020
12:38:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF9WInitial Entry
5.d
Date Location User Value Reason
Sep-16-2020
12:38:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPHF9
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-16-2020
12:38:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHF9XInitial Entry
090177e196ae30e9\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-2021-5683-0815360
Page 171 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
12:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
12:39:00
(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-16-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
12:39:00
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815361
Page 172 of 305
***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: 11691056 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-16-2020
12:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP0T3
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T3SInitial Entry
090177e196ae30e9\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-2021-5683-0815362
Page 173 of 305
***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: 11691056 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-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815363
Page 174 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
Sep/16/2020 12:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020
13:00:26
(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-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815364
Page 175 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020
13:00:26
(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-16-2020
13:00:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815365
Page 176 of 305
***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: 11691056 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-16-2020
13:00:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Thomas
EamesData Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815366
Page 177 of 305
***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: 11691056 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-08-2020
10:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815367
Page 178 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30e9\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-2021-5683-0815368
Page 179 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-08-2020
10:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30e9\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-2021-5683-0815369
Page 180 of 305
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815370
Page 181 of 305
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-08-2020
10:07:55
(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:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815371
Page 182 of 305
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020
10:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815372
Page 183 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
13:01:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
13:01:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
13:01:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-08-2020
13:01:30
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815373
Page 184 of 305
***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: 11691056 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-08-2020
13:01:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020
13:01:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0T8
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
13:01:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0T82Initial Entry
090177e196ae30e9\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-2021-5683-0815374
Page 185 of 305
***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: 11691056 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
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815375
Page 186 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 09:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815376
Page 187 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020
10:08:22
(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
Oct-08-2020
10:08:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815377
Page 188 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
16:28:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-10-2020
11:35:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Nov-10-2020
04:58:44
(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
090177e196ae30e9\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-2021-5683-0815378
Page 189 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
EOT to match
date of visit at
visit 3.
Nov-09-2020
11:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815379
Page 190 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-09-2020
11:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-09-2020
11:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-09-2020
11:19:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-09-2020
11:18:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815380
Page 191 of 305
***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: 11691056 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.
Nov-09-2020
11:18:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Nov/9/2020Initial Entry
5.a
Date Location User Value Reason
Nov-09-2020
11:19:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0TB
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-09-2020
11:19:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0TBVInitial Entry
5.b
090177e196ae30e9\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-2021-5683-0815381
Page 192 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-09-2020
11:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHFL
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-09-2020
11:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFL7Initial Entry
5.c
Date Location User Value Reason
Nov-09-2020
11:19:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHFL
8Initial Entry
090177e196ae30e9\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-2021-5683-0815382
Page 193 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Nov-09-2020
11:19:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFL8Initial Entry
5.d
Date Location User Value Reason
Nov-09-2020
11:20:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHFL
9Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-09-2020
11:20:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFL9Initial Entry
090177e196ae30e9\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-2021-5683-0815383
Page 194 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-24-2020
15:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
15:02:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Nov-24-2020
15:02:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815384
Page 195 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-24-2020
15:02:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/24/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-24-2020
15:02:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815385
Page 196 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/24/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-22-2021
04:19:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-19-2021
13:58:32
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answered Symptoms
remain
ongoing
090177e196ae30e9\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-2021-5683-0815386
Page 197 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
Feb-12-2021
06:48:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 60 days have
passed since
the Date of
First
Symptom
Started and
Ongoing is
YES. Please
confirm if
symptoms are
truly ongoing.
Else, please
enter Date of
Last
Symptom
Resolved.
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:YESInitial Entry
090177e196ae30e9\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-2021-5683-0815387
Page 198 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.a Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:YESInitial Entry
090177e196ae30e9\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-2021-5683-0815388
Page 199 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.b Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom
Prese
nt:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815389
Page 200 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.c Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815390
Page 201 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.d Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:YESInitial Entry
090177e196ae30e9\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-2021-5683-0815391
Page 202 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.e Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815392
Page 203 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.f Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815393
Page 204 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.g Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815394
Page 205 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.h Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom
Present:NOInitial Entry
090177e196ae30e9\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-2021-5683-0815395
Page 206 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.i Symptoms:
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-24-2020
15:04:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-24-2020
15:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Heada
cheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-24-2020
15:06:59ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
090177e196ae30e9\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-2021-5683-0815396
Page 207 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
5.b
Date Location User Value Reason
Nov-24-2020
15:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Fatig
ueInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-24-2020
15:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815397
Page 208 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815398
Page 209 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/24/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae30e9\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-2021-5683-0815399
Page 210 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815400
Page 211 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-30-2020
14:25:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-30-2020
11:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New
Information
Nov-30-2020
11:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Clia Certified labNew
Information
Nov-29-2020
15:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Query:
Per CRF CRs
8.31.7, please
provide
manufacturer
and test kit
name. If not
available,
please enter if
test conducted
at 'CLIA-
certified lab' or
'ISO 15189
accredited lab.'
090177e196ae30e9\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-2021-5683-0815401
Page 212 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If both trade
name and lab
are not known,
enter 'NALT
Unknown.'
Nov-27-2020
13:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815402
Page 213 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
15:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
15:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
15:03:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
15:03:13
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815403
Page 214 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 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.
Nov-24-2020
15:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020
15:03:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:RW8591
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
15:03:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RW85915Initial Entry
090177e196ae30e9\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-2021-5683-0815404
Page 215 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
15:08:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
15:08:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
15:08:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815405
Page 216 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-24-2020
15:08:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subject did a self swa
b at home.Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815406
Page 217 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30e9\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-2021-5683-0815407
Page 218 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMER
GENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
090177e196ae30e9\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-2021-5683-0815408
Page 219 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae30e9\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-2021-5683-0815409
Page 220 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of
Practitio
ner:URGENT
CARE
Occurre
nce of Vi
sits or C
ontacts:YES
Number
of Visits
or Conta
cts:
1Initial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or
Contacts:
1Initial Entry
1.e
090177e196ae30e9\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-2021-5683-0815410
Page 221 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of
Practitio
ner:TELEPHO
NE CONS
ULTATIO
N
Occurre
nce of Vi
sits or C
ontacts:YES
Number
of Visits
or Conta
cts:
1Initial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or
Contacts:
1Initial Entry
090177e196ae30e9\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-2021-5683-0815411
Page 222 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-24-2020
15:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae30e9\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-2021-5683-0815412
Page 223 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-24-2020
15:10:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815413
Page 224 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/24/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-27-2020
13:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-27-2020
13:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-27-2020
13:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815414
Page 225 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1169 Site Name: (1169) Lehigh Valley Hospital
Subject No: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-29-2020
11:22:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/29/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-29-2020
11:22:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815415
Page 226 of 305
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-29-2020
11:26:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-29-2020
11:26:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-29-2020
11:26:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-29-2020
11:26:09
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815416
Page 227 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11691056 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.
Dec-29-2020
11:26:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Dec/29/2020Initial Entry
5.a
Date Location User Value Reason
Dec-29-2020
11:26:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP0TC
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-29-2020
11:26:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0TCCInitial Entry
5.b
090177e196ae30e9\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-2021-5683-0815417
Page 228 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-29-2020
11:26:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF
MRInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-29-2020
11:26:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFMRInitial Entry
5.c
Date Location User Value Reason
Dec-29-2020
11:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF
MSInitial Entry
090177e196ae30e9\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-2021-5683-0815418
Page 229 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Dec-29-2020
11:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFMSInitial Entry
5.d
Date Location User Value Reason
Dec-29-2020
11:27:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPHF
MTInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-29-2020
11:27:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPHFMTInitial Entry
090177e196ae30e9\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-2021-5683-0815419
Page 230 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-09-2020
13:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815420
Page 231 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-10-2020
11:35:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-09-2020
13:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815421
Page 232 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020
11:18:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815422
Page 233 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020
11:19:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815423
Page 234 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Dec-15-2020
13:38:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815424
Page 235 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Dec-29-2020
12:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815425
Page 236 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Dec-29-2020
12:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815426
Page 237 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-13-2021
09:41:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30e9\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815427
Page 238 of 305
***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: 11691056 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-13-2021
09:42
…[truncated]
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Kenneth Yan Permanent Address: U.S. Citizen) Emai • Cell: PROFESSIONAL SUMMARY • Extensive knowledge and exposure in all phases of clinical trials in different therapeutic areas such as Oncology, Central Nervous system a…
EFTA00267943 — Dear Ms Pearce,
Dear Ms Pearce, Yours sincerely, NUT Pl CASE sFC;K ccRRCPT ION cor-lfrimSioNER* ' PRA0e TO vi cri OCcomeNTE-13 EU I beNce or Cere4STRecTE.D CIISE Fur W,QOUJIN)Csi seNEY'rce-s _ t,wci_A; et-ic-NT cCRikePnc.N treigca ---7 …
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Federal Writers' Project

[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Early Portland Folkways]
Pee -Ors 4"J er,i7vAls -retA",10**ErS, Amnion no. WPA L. C. PROJECT UNIT Form -3 /J-F'd Date received 47, Consignment no. Shipped from Label AV:al-4 514 Amount olv Collection (or Type) Title Date...11,4/ Place of origin …
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