Document text
Page 1 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912042
Page 2 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912043
Page 3 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10471194]
2.Birth Date: /1962
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:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0912044
Page 4 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912045
Page 5 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912046
Page 6 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912047
Page 7 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[COPD]
Start Date: UNK/UNK/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right Knee Injury]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Left Hip Broken]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912048
Page 8 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Restless Leg Syndrome]
Start Date: UNK/UNK/2000
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right Knee Replacement]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912049
Page 9 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Left Hip Replacement]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastric Bypass]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912050
Page 10 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastric Bypass Reversal]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right Knee ACL Repair]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912051
Page 11 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [208.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [33.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912052
Page 12 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912053
Page 13 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [258315]
3.Randomization Group: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912054
Page 14 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BJLLZF]
5.bSample ID [BJLLZG]
5.cSample ID [BJLLYJ]
5.dSample ID [BLB6F5]
5.eSample ID [BLB6F6]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912055
Page 15 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BJLLZ5]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912056
Page 16 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/11/2020 16:33
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
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912057
Page 17 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912058
Page 18 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912059
Page 19 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912060
Page 20 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912061
Page 21 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BPSYX6] Comments
5.bSample ID [BR8FWH] Comments
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912062
Page 22 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?YES
Date of First Delay:
Oct/2/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/19/2020 13:49
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
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912063
Page 23 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912064
Page 24 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BPSXYD]
5.bSample ID [BPSXYF]
5.cSample ID [BPSXYG]
5.dSample ID [BSHP52]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912065
Page 25 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912066
Page 26 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/10/2021
2.Date of First Symptom
Started:Feb/2/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/8/2021
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912067
Page 27 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912068
Page 28 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Feb/4/2
021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912069
Page 29 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/4/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: HOLOGIC PANTHER FUSION SARS-COV-2
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912070
Page 30 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV34559]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912071
Page 31 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:[No office visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912072
Page 32 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912073
Page 33 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?YES
Has the subject been in intensive care due to potential
COVID-19 illness?
NO
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912074
Page 34 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Catego
ryHospitalization
TermAdmission
DateOngoing Form Instance
1.HOSPITALIZATION ST
ATUS HOSPITAL Feb/4/2021 NO
Discharge D
ate:
Feb/8/2021
Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912075
Page 35 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/4/2021
4.Ongoing? NO
Discharge Date:
Feb/8/2021
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912076
Page 36 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912077
Page 37 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912078
Page 38 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 3
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912079
Page 39 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912080
Page 40 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912081
Page 41 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category
for Lab T
estVendor Na
meCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY Gadsden Re
gional Medi
cal Center
1007 Goody
ear Avenue
Gadsden AL
39503 Feb/4/
2021 BLOO
D Sponsor-
Defined I
dentifierTest:Resu
lt:
329 C Reactive P
rotein_PX32
9 [ ]
30 Alanine Ami
notransferas
e_PX30 28 I
U/L
28 Aspartate A
minotransfer
ase_PX28 89IU
/L
35 Alkaline Pho
sphatase_PX
35 87IU
/L
21 Bilirubin_P
X21 0.8m
g/dl
47 Blood Urea
Nitrogen_P
X47 10m
g/dL
48 Creatinine_P
X48 0.80
mg/d
L Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912082
Page 42 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[Gadsden Regional Medical Center
1007 Goodyear Avenue
Gadsden AL 39503]
3.Collection Date: Feb/4/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912083
Page 43 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [28 IU/L]
Not Done:
LNMT Low
[5]
High
[50]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [89IU/L]
Not Done:
LNMT Low
[14]
High
[40]
Unit
U/L
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912084
Page 44 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [87IU/L]
Not Done:
LNMT Low
[14]
High
[90]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.8mg/dl]
Not Done:
LNMT Low
[0.2]
High
[1.5]
Unit
mg/L
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912085
Page 45 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [10mg/dL]
Not Done:
LNMT Low
[7]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.80 mg/dL]
Not Done:
LNMT Low
[0.70]
High
[1.50]
Unit
mg/dL
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912086
Page 46 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
y for La
b TestVendor Nam
e (DERIVE
D)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.HEMAT
OLOGY Gadsden Reg
ional Medica
l Center
1007 Goodye
ar Avenue
Gadsden, AL
39503 Feb/4/
2021 BLOO
D Sponsor-
Defined I
dentifierTest:Result:
1 Hemogl
obin_PX
1 13.1 gm
/dL
2 Hematoc
rit_PX2 40.8%
3 Erythroc
ytes_PX
3 5.01X1
0^6/mcl
5 Platelets
_PX5 216x10
^3/mcl
7 Leukocy
tes_PX7 11.14x1
0^3/mcl
HI
608 Neutrop
hils_PX
608 86.7%
HI
609 Eosinop
hils_PX
609 1.9%
612 Monocyt
es_PX61
2 7.0% Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912087
Page 47 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
y for La
b TestVendor Nam
e (DERIVE
D)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Result:
610 Basophil
s_PX610
0.4%
611 Lympho
cytes_P
X611 3.6% lo
w
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912088
Page 48 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[Gadsden Regional Medical Center
1007 Goodyear Avenue
Gadsden, AL 39503]
3.Collection Date: Feb/4/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.1 gm/dL]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912089
Page 49 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.8%]
Not Done:
LNMT Low
[37.0]
High
[47.0]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.01X10^6/mcl]
Not Done:
LNMT Low
[4.20]
High
[5.40]
Unit
10^6/cu mm
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912090
Page 50 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [216x10^3/mcl]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [11.14x10^3/mcl HI]
Not Done:
LNMT Low
[4.80]
High
[10.80]
Unit
10^3/uL
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912091
Page 51 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [86.7% HI]
Not Done:
LNMT Low
[2.70]
High
[7.70]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [1.9%]
Not Done:
LNMT Low
[0.0]
High
[9.4]
Unit
%
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912092
Page 52 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [7.0%]
Not Done:
LNMT Low
[1.0]
High
[8.8]
Unit
%
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.4%]
Not Done:
LNMT Low
[0.0]
High
[1.4]
Unit
%
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912093
Page 53 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [3.6% low]
Not Done:
LNMT Low
[19.7]
High
[50.2]
Unit
%
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912094
Page 54 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1.Feb/4/2021 Record Identifier: Systolic: Diastolic:
1 148 91 Repeating Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912095
Page 55 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/4/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [148]
Diastolic: [91] Comments
Respiratory Rate in
respirations/minute:[19]
Heart Rate in
beats/minute:[101]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912096
Page 56 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1.Feb/8/2021 Record Identifier: Oxygen Saturation
1 94.0 Repeating Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912097
Page 57 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/8/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912098
Page 58 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912099
Page 59 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912100
Page 60 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912101
Page 61 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912102
Page 62 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Feb/4/2021 CHEST X-RAY NORMAL Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912103
Page 63 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/4/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912104
Page 64 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912105
Page 65 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912106
Page 66 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912107
Page 67 of 366
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912108
Page 68 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912109
Page 69 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912110
Page 70 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912111
Page 71 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912112
Page 72 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Fractured Left Elb
ow Nov/6/2020
14:00 NO
End Date Time:
Dec/15/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT 2 Fall Nov/6/2020
UNK:UNK NO
End Date Time:
Nov/6/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT 3 Dyspena with exac
erbation of COPD Feb/4/2021
UNK:UNK NO
End Date Time:
Feb/7/2021 UN
K:UNK
Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912113
Page 73 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Fractured Left Elbow]
4.Start Date Time: Nov/6/2020 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912114
Page 74 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912115
Page 75 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912116
Page 76 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Fall]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912117
Page 77 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[accident]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912118
Page 78 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912119
Page 79 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Dyspena with exacerbation of COPD]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/7/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912120
Page 80 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[exacerbation of known COPD]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912121
Page 81 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[2021139175]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912122
Page 82 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912123
Page 83 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912124
Page 84 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO Influenza V
accine Oct/2/
2020 Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912125
Page 85 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Influenza Vaccine]
5.Date: Oct/2/2020
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912126
Page 86 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912127
Page 87 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912128
Page 88 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912129
Page 89 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912130
Page 90 of 366
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912131
Page 91 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912132
Page 92 of 366
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912133
Page 93 of 366
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912134
Page 94 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912135
Page 95 of 366
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912136
Page 96 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912137
Page 97 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912138
Page 98 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912139
Page 99 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912140
Page 100 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912141
Page 101 of 366
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912142
Page 102 of 366
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912143
Page 103 of 366
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912144
Page 104 of 366
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912145
Page 105 of 366
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912146
Page 106 of 366
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912147
Page 107 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/16/2020
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912148
Page 108 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912149
Page 109 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 22:14:28 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0912150
Page 110 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-11-2020 16:56:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912151
Page 111 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912152
Page 112 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912153
Page 113 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912154
Page 114 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912155
Page 115 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912156
Page 116 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912157
Page 117 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912158
Page 118 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912159
Page 119 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-12-2020 10:47:57 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912160
Page 120 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912161
Page 121 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912162
Page 122 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912163
Page 123 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912164
Page 124 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912165
Page 125 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912166
Page 126 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912167
Page 127 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912168
Page 128 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 14:43:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912169
Page 129 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 09:15:51 (UTC-06:00)
Central Time (US & Canada)2 nasal swabs were collected due to
temporary delay of vaccine. One
was collected on 02Oct2020 and the
second was collected on 19Oct2020
when patient returned for Vax2.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912170
Page 130 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-04-2020 09:14:01 (UTC-06:00)
Central Time (US & Canada)Swab was also collected on
02Oct2020 with barcode # BPSYX6
then patient had a temporary delay
due to receiving the Flu Shot the same
day. Patient returned for Vax 2 on
19Oct2020 and a repeat swab was
collected with barcode #BR8FWH.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912171
Page 131 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-06-2020 09:20:19 (UTC-06:00)
Central Time (US & Canada)sample collected 02Oct2020 and then
determined that a temporary delay
was needed. Sample was recollected
on 19Oct2020.
5.bNov-06-2020 09:18:40 (UTC-06:00)
Central Time (US & Canada)Sample collected 02Oct2020 but due
to temporary delay sample should be
destroyed since it was repeated on
10Oct2020.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912172
Page 132 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-12-2021 08:25:39 (UTC-06:00)
Central Time (US & Canada)not clinically significant
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912173
Page 133 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 22:14:28 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-04-2021 09:28:26 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 08:58:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0912174
Page 134 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, 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-19-2020 15:37:26 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-17-2020 10:52:20 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0912175
Page 135 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Nov-16-2020 15:51:41 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 12:23:18 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0912176
Page 136 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020
16:55:08
(UTC-06:00)
Central 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-11-2020
16:55:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912177
Page 137 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020
16:55:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/11/2020Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912178
Page 138 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020
16:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10471194Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020
16:54:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1962Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020
16:55:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912179
Page 139 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
16:55:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020
16:55:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912180
Page 140 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
16:55:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912181
Page 141 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020
16:56:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020
16:56:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020
16:56:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912182
Page 142 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-12-2020
10:49:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:COPD
Start Date: UNK/U
NK/201
2
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:49:07
(UTC-06:00)
Central 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-12-2020
10:49:07
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
COPDInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912183
Page 143 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-12-2020
10:49:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-12-2020
10:49:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-12-2020
10:49:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Right Kne
e Injury
Start Date
:UNK/UN
K/2011Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912184
Page 144 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date
:
UNK/U
NK/201
1
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912185
Page 145 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:49:54
(UTC-06:00)
Central 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-12-2020
10:49:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Right Knee InjuryInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-12-2020
10:49:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-12-2020
10:49:54ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912186
Page 146 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2011
1.c
Date Location User Value Reason
Sep-12-2020
10:50:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Left Hip B
roken
Start Date
:UNK/UN
K/2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912187
Page 147 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:50:41
(UTC-06:00)
Central 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-12-2020
10:50:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Left Hip BrokenInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-12-2020
10:50:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-12-2020
10:50:41ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912188
Page 148 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2019
1.d
Date Location User Value Reason
Sep-12-2020
10:51:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Anxiety
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912189
Page 149 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:51:16
(UTC-06:00)
Central 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-12-2020
10:51:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-12-2020
10:51:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-12-2020
10:51:16ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912190
Page 150 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Sep-12-2020
10:51:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Restless L
eg Syndro
me
Start Date
:UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912191
Page 151 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:51:40
(UTC-06:00)
Central 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-12-2020
10:51:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Restless Leg Syndro
meInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-12-2020
10:51:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-12-2020
10:51:40ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912192
Page 152 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-12-2020
10:52:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History T
erm:Right Knee
Replaceme
nt
Start Dat
e:UNK/UNK/
2011
Ongoing: NO
End Date:
UNK/U
NK/201
1Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912193
Page 153 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:52:26
(UTC-06:00)
Central 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-12-2020
10:52:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Right Knee Replace
mentInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-12-2020
10:52:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-12-2020
10:52:26ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912194
Page 154 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2011
1.g
Date Location User Value Reason
Sep-12-2020
10:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:Left Hip R
eplacement
Start Dat
e:UNK/UNK
/2019
Ongoing: NO
End Date:
UNK/U
NK/201
9Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912195
Page 155 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:53:03
(UTC-06:00)
Central 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-12-2020
10:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Left Hip Replacemen
tInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-12-2020
10:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-12-2020
10:53:03ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912196
Page 156 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2019
1.h
Date Location User Value Reason
Sep-12-2020
10:53:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:Hysterecto
my
Start Date
:UNK/UN
K/1995
Ongoing: NO
End Date
:
UNK/U
NK/199
5Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912197
Page 157 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:53:45
(UTC-06:00)
Central 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-12-2020
10:53:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HysterectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-12-2020
10:53:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-12-2020
10:53:45ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912198
Page 158 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1995
1.i
Date Location User Value Reason
Sep-12-2020
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:Gastric By
pass
Start Date
:UNK/UN
K/1993
Ongoing: NO
End Date
:
UNK/U
NK/199
3Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912199
Page 159 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Gastric BypassInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-12-2020
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1993Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-12-2020
10:54:26ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912200
Page 160 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1993
1.j
Date Location User Value Reason
Sep-12-2020
10:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical
History T
erm:Gastric Byp
ass Reversa
l
Start Dat
e:UNK/UNK
/2000
Ongoing: NO
End Date:
UNK/U
NK/200
0Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912201
Page 161 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020
10:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Gastric Bypass Reve
rsalInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-12-2020
10:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-12-2020
10:55:05ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912202
Page 162 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2000
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912203
Page 163 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Sep-12-2020
10:55:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:Right Knee
ACL Repai
r
Start Dat
e:UNK/UNK
/2011
Ongoing: NO
End Date:
UNK/U
NK/201
1Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912204
Page 164 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-12-2020
10:55:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020
10:55:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Right Knee ACL Re
pairInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-12-2020
10:55:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-12-2020
10:55:47ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912205
Page 165 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2011
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912206
Page 166 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
208.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912207
Page 167 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-12-2020
10:48:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.6Initial Entry
7.a
Date Location User Value Reason
Sep-12-2020
10:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:97.3Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912208
Page 168 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-12-2020
10:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-12-2020
10:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-12-2020
10:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912209
Page 169 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-12-2020
10:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912210
Page 170 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912211
Page 171 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912212
Page 172 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-12-2020
10:47:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-12-2020
10:47:57ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912213
Page 173 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912214
Page 174 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020
16:57:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020
16:57:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
258315Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912215
Page 175 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
17:15:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
17:15:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
17:15:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
17:15:40
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912216
Page 176 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
17:15:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
17:15:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BJLLZ
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
17:15:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BJLLZFInitial Entry
5.b
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912217
Page 177 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-11-2020
17:16:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BJLLZ
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
17:16:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BJLLZGInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020
17:16:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BJLLY
JInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912218
Page 178 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
17:16:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BJLLYJInitial Entry
5.d
Date Location User Value Reason
Sep-11-2020
17:16:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLB6F
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-11-2020
17:16:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLB6F5Initial Entry
5.e
Date Location User Value Reason
Sep-11-2020
17:16:38ACV0PFEINFP6000 Data Entry:
Sample ID BLB6FInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912219
Page 179 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada): 6
5.e Sample ID
Date Location User Value Reason
Sep-11-2020
17:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLB6F6Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912220
Page 180 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
17:16:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
17:16:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
17:17:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
17:16:55
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912221
Page 181 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
17:16:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
17:17:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BJLLZ
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
17:17:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BJLLZ5Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912222
Page 182 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912223
Page 183 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020 16:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912224
Page 184 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
16:57:26
(UTC-06:00)
Central 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-11-2020
16:57:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912225
Page 185 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020
16:57:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912226
Page 186 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020
08:39:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Changed
Information
Oct-02-2020
14:42:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912227
Page 187 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-03-2020
08:39:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Changed
Information
Oct-20-2020
03:30:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query.
Oct-19-2020
15:14:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Original value
is correct
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital Signs
Date is not
same as
Vaccination
Date in the
same visit.
Please review
and update as
appropriate or
clarify.
Oct-02-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912228
Page 188 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14:42:58
(UTC-06:00)
Central Time (US
& Canada)Oct/2/2020
2.a
Date Location User Value Reason
Nov-03-2020
08:39:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperatu
re:97.7
Temperatu
re Unit:F
Temperatu
re Locatio
n::FORE
HEA
DChanged
Information
Oct-02-2020
14:42:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Locatio
n::FORE
HEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912229
Page 189 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020
14:42:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-03-2020
08:39:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.7Changed
Information
Oct-02-2020
14:42:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020
14:42:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912230
Page 190 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020
14:42:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912231
Page 191 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912232
Page 192 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912233
Page 193 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-02-2020
14:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-02-2020
14:43:13ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912234
Page 194 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912235
Page 195 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
14:54:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
14:54:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
10:16:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Closed Response
satisfies query
Nov-06-2020
10:16:19
(UTC-06:00)ACV0PFEINFP6000 Query 5: Closed Response
satisfies query
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912236
Page 196 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
Nov-06-2020
09:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Answere
dChanged data
per query
Nov-06-2020
09:18:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 5: Answere
dChanged data
per query
Nov-06-2020
09:17:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened There are more
than 1 barcode
present for
sample
collection.
Please review
and correct as
appropriate.
Nov-06-2020
09:10:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Opened LIMS: Nasal
Swab barcode
BR8FWH was
received by the
lab for Visit 2.
Please consider
entering both
barcodes
including the
destroyed
barcode for
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912237
Page 197 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
this visit.
Please review
and update or
clarify.
Nov-06-2020
00:59:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Nov-05-2020
08:29:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dChanged data
per query
Nov-05-2020
00:28:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued
:OpenedHOLDS 2:
Thank you for
the response.
However,
Nasal Swab
barcode
BPSYX6 was
received by the
lab for Visit 2.
Please confirm
submission of
SCF with
correct data to
the lab.
Else,clarify.
Nov-04-2020
09:10:22ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answere
dTranscription
Error
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912238
Page 198 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Nov-04-2020
09:10:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Oct/19/2020Transcription
Error
Nov-04-2020
05:05:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued
:OpenedHOLDS 2:
Nasal Swab
barcode
BPSYX6 was
received by the
lab for Visit 2.
Please review
and confirm
the correct visit
for this sample
else Please
submit an
updated SCF
and confirm
submission.
Thank you.
Nov-03-2020
08:41:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dpatient had
delay in
vaccination
due to flu shot,
patient
completed 2
nasal swabs,
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912239
Page 199 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
one on Oct 2nd
2020 and one
on Oct 19
2020. Both
swabs are
correct
Nov-02-2020
23:45:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued
:OpenedHOLDS 1:
Thank you for
the response.
However,
Nasal Swab
barcode
BPSYX6 was
received by the
lab for Visit 2.
Please confirm
submission of
SCF with
correct data to
the lab.
Else,clarify.
Nov-02-2020
14:43:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dBarcode
BR8FWH is
correct.
Nov-02-2020
03:24:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened HOLDS: Nasal
Swab barcode
BPSYX6 was
received by the
lab for Visit 2.
Please review
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912240
Page 200 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and confirm
the correct visit
for this sample.
Oct-20-2020
03:30:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query.
Oct-19-2020
15:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answere
dOriginal value
is correct
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of
Collection is
more than 1
day before
Dose Date on
the Vaccination
form. Please
review and
update as
appropriate,
else clarify.
Oct-02-2020
14:54:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
14:54:11ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912241
Page 201 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-02-2020
14:54:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020
08:28:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPSY
X6Transcription
Error
Oct-02-2020
14:54:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR8FW
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020
08:28:53ACV0PFEINFP6000 Data Entry:
BPSYX6Transcription
Error
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912242
Page 202 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Oct-02-2020
14:54:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8FWHInitial Entry
5.b
Date Location User Value Reason
Nov-06-2020
09:17:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR8FW
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020
09:17:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8FWHInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912243
Page 203 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020
18:59:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-06-2020
12:59:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Changed data
per query
Oct-05-2020
19:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery:
Please add the
Recent Non
Study
Vaccination to
the CRF that
led to the delay
of study Vac at
Visit 2
Oct-02-2020
15:16:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-02-2020
15:16:46ACV0PFEINFP6000 Data Entry:
YESTranscription
Error
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912244
Page 204 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Date of First Dela
y:
Oct/2/2020
Reason(s) for Te
mporary Delay of
Vaccination
RECENT NON-
STUDY VACCI
NATION
Oct-02-2020
15:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Was there a
temporary
delay of
vaccination?' is
marked as Yes
and 'Date of
First Delay' is
not entered.
Please review
and update as
appropriate.
Oct-02-2020
15:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Reason(s) for Te
mporary Delay of
Vaccination
RECENT NON-
STUDY VACCI
NATIONInitial Entry
2. Treatment Name
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912245
Page 205 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-03-2020
15:59:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Nov-03-2020
08:41:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answere
dOriginal value is
correct
Nov-03-2020
00:35:05
(UTC-06:00)ACV0PFEINFP6000 Query 2: Reissued
:OpenedThanks for the
response, form
has been
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0912246
Page 206 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)unfreeze, please
update as per
below query
Nov-02-2020
03:49:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued
:CandidatePlease unfreeze
whole visit so
VS form can be
updated. Thank
you.
Oct-30-2020
09:00:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answere
dif you will
unfreeze the
whole visit and
reissue the
query so I can
update the
correct visit
date.
Oct-28-2020
13:00:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery:
Pre-vaccination
procedures
(vital signs,
nasal swabs and
pregnancy tests)
must be
conducted on
the same day as
vaccination.
Vital signs
collection date
does not equal
vaccination
date. Please
review/update,
or confirm data
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912247
Page 207 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
correct as-is.
Oct-20-2020
03:30:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query.
Oct-19-2020
15:13:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dtemporary delay
due to patient
receiving flu
vaccine on
original day of
visit 2
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date is not
equal to Date of
Visit
02/Oct/2020 of
the
corresponding
Visit. Please
review and
update as
appropriate.
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020 13:4
9Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912248
Page 208 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912249
Page 209 of 366
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-19-2020
15:12:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912250
Page 210 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
15:51:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912251
Page 211 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020
07:57:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020
07:57:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020
07:57:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-17-2020
07:57:36
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912252
Page 212 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-17-2020
07:57:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Nov/16/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020
07:57:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPSXY
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020
07:57:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPSXYDInitial Entry
5.b
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912253
Page 213 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-17-2020
07:57:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPSXY
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-17-2020
07:57:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPSXYFInitial Entry
5.c
Date Location User Value Reason
Nov-17-2020
07:58:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPSXY
GInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912254
Page 214 of 366
***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, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Nov-17-2020
07:58:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPSXYGInitial Entry
5.d
Date Location User Value Reason
Nov-17-2020
07:58:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSHP5
2Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-17-2020
07:58:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSHP52Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0912255
Page 215 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
01:39:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-17-2021
14:31:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dAnswer Auto
Query
Feb-17-2021
08:54:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued
:OpenedRe-issue by
16Feb if data
is not updated
Feb-12-2021
14:02:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued
:CandidateRe-issue by
16Feb if data
is not updated
Feb-12-2021
09:48:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dpending,
patient is
collecting
swab and we
are waiting for
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912256
Page 216 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Marken to
notify us of
pickup and
arrival of the
swab. We will
complete the
information as
soon as we
receive it.
Feb-12-2021
01:19:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit
is completed
but Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Feb-11-2021
13:13:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
eDate of Visit
is completed
but Date of
Assessment in
the Signs and
Symptoms
form is
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0912257
Page 217 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
missing.
Please review
and update as
appropriate.
Feb-11-2021
13:13:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eDate of Visit
is completed
but Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Feb-11-2021
13:13:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-11-2021
13:13:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0912258
Page 218 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-11-2021
13:40:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-11-2021
13:40:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Transcription
Error
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of
assessment is
not same as
Date Visit.
Please check
and correct.
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912259
Page 219 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Sympto
m Resolved:
Feb/8/2021Initial Entry
4.a
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912260
Page 220 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
4.a Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912261
Page 221 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom P
resen
t:YESInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912262
Page 222 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912263
Page 223 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912264
Page 224 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.e Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912265
Page 225 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912266
Page 226 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912267
Page 227 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912268
Page 228 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i Symptoms:
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-11-2021
13:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912269
Page 229 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912270
Page 230 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912271
Page 231 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-11-2021
13:15:17
(UTC-06:00)
Central 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
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HOLOGIC PANTHE
R FUSION SARS-CO
V-2Initial Entry
7. Test Result:
Date Location User Value Reason
Feb-11-2021
13:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912272
Page 232 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021
14:31:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021
14:31:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021
14:31:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-17-2021
14:31:13
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0912273
Page 233 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-17-2021
14:31:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Feb/11/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021
14:31:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:CV3455
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021
14:31:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CV34559Initial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0912274
Page 234 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021
13:15:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021
13:15:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-11-2021
13:15:52
(UTC-06:00)
Central 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:
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912275
Page 235 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-11-2021
13:15:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
No office visitInitial Entry
090177e196ae3082\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0912276
Page 236 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subj
…[truncated]