125742 S1 M5 CRF c4591001 1037 10371052

Document text

Page 1 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903860
Page 2 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
Aug/24/2020
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903861
Page 3 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10371052]
2.Birth Date: /1975
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903862
Page 4 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903863
Page 5 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903864
Page 6 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903865
Page 7 of 259
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:[OBESITY]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/1997
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANXIETY]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903866
Page 8 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BIPOLAR DEPRESSION]
Start Date: UNK/UNK/2016
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[UTERINE SCARRING]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2017
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Exercise induced Asthma]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903867
Page 9 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [83.9]
3.Unit: kg
4.Height: [162.6]
5.Unit: cm
6.Body Mass Index: [31.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903868
Page 10 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903869
Page 11 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [63425]
3.Randomization Group: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903870
Page 12 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Aug/24/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBBMC]
5.bSample ID [BLBBMD]
5.cSample ID [BN5SB3]
5.dSample ID [BN5SB4]
5.eSample ID [BN5SB5]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903871
Page 13 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Aug/24/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5SB8]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903872
Page 14 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: Aug/24/2020 09:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903873
Page 15 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903874
Page 16 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903875
Page 17 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903876
Page 18 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903877
Page 19 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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/14/2020
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 [BP7HV3]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903878
Page 20 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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/14/2020 14:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903879
Page 21 of 259
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903880
Page 22 of 259
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Oct/12/2020
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 [BK6YM8]
5.bSample ID [BLBB99]
5.cSample ID [BKP236]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903881
Page 23 of 259
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903882
Page 24 of 259
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Mar/9/2021
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 [BRSNF3]
5.bSample ID [BS6MHH]
5.cSample ID [BRJPNL]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903883
Page 25 of 259
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903884
Page 26 of 259
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903885
Page 27 of 259
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903886
Page 28 of 259
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903887
Page 29 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903888
Page 30 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/20/2021
2.Date of First Symptom Started: Nov/UNK/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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
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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903889
Page 31 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [INCREASED SEASONAL ALLERGIES]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903890
Page 32 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Instan
ce
 1.Jan/15/20
21 SWABBED
MATERIAL
 NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903891
Page 33 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: Jan/15/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903892
Page 34 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Jan/21/2021
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 [CV06550]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903893
Page 35 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:[due to self swab collection no office swab was completed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903894
Page 36 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903895
Page 37 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903896
Page 38 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.        Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903897
Page 39 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Hospitalization Details
1.Hospitalization Category:
2.Hospitalization Term:
3.Admission Date: //
4.Ongoing?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903898
Page 40 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903899
Page 41 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903900
Page 42 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: 1
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903901
Page 43 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903902
Page 44 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903903
Page 45 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903904
Page 46 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903905
Page 47 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903906
Page 48 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903907
Page 49 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:
  [ ]  [ ] Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903908
Page 50 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903909
Page 51 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen Saturation
  [ ] Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903910
Page 52 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903911
Page 53 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyg
en)Form Instance
 1.      Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903912
Page 54 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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):[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903913
Page 55 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903914
Page 56 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903915
Page 57 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903916
Page 58 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903917
Page 59 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903918
Page 60 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
Feb/24/2021
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 [BS6MG0]
5.bSample ID [BRSNCL]
5.cSample ID [BRJPM3]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903919
Page 61 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903920
Page 62 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903921
Page 63 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903922
Page 64 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903923
Page 65 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903924
Page 66 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903925
Page 67 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  FLU LIKE SYMP
TOMS Sep/18/2020 12:0
0 NO
End Date Time:
Sep/20/2020 UNK:U
NK
 Repeating
Pages
 2.ADVERSE E
VENT 2  LOW GRADE FE
VER Aug/24/2020 13:0
0 NO
End Date Time:
Aug/25/2020 08:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  EAR ACHE  Sep/18/2020 UN
K:UNK NO
End Date Time:
Sep/28/2020 UNK:U
NK
 Repeating
Pages
 4.ADVERSE E
VENT 4  DIARRHEA  Aug/25/2020 UN
K:UNK NO
End Date Time:
Sep/23/2020 UNK:U
NK
 Repeating
Pages
 5.ADVERSE E
VENT 5  SHORTNESS OF
BREATH Nov/UNK/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903926
Page 68 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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)[FLU LIKE SYMPTOMS]
4.Start Date Time: Sep/18/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903927
Page 69 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903928
Page 70 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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)[LOW GRADE FEVER]
4.Start Date Time: Aug/24/2020 13:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/25/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903929
Page 71 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903930
Page 72 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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)[EAR ACHE]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903931
Page 73 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[SEASONAL ALLERGIES]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903932
Page 74 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[DIARRHEA]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903933
Page 75 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903934
Page 76 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: [5]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[SHORTNESS OF BREATH]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903935
Page 77 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021107035]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903936
Page 78 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication
ErrorStart D
ateIs the medication error Stil
l OngoingStudy Medication Erro
rs ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903937
Page 79 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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[ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903938
Page 80 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903939
Page 81 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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.Date: //
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903940
Page 82 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903941
Page 83 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903942
Page 84 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903943
Page 85 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903944
Page 86 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903945
Page 87 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903946
Page 88 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903947
Page 89 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903948
Page 90 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903949
Page 91 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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?
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903950
Page 92 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903951
Page 93 of 259
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903952
Page 94 of 259
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903953
Page 95 of 259
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903954
Page 96 of 259
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903955
Page 97 of 259
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903956
Page 98 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903957
Page 99 of 259
***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, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903958
Page 100 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903959
Page 101 of 259
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903960
Page 102 of 259
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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: [ ]
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903961
Page 103 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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 Oct/12/2020
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903962
Page 104 of 259
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903963
Page 105 of 259
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903964
Page 106 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 11:09:39 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903965
Page 107 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 14:08:41 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903966
Page 108 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Aug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903967
Page 109 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Aug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903968
Page 110 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Aug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903969
Page 111 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Aug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903970
Page 112 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Aug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903971
Page 113 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903972
Page 114 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903973
Page 115 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903974
Page 116 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-15-2020 08:35:56 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903975
Page 117 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903976
Page 118 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903977
Page 119 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903978
Page 120 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903979
Page 121 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903980
Page 122 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903981
Page 123 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903982
Page 124 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 08:35:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903983
Page 125 of 259
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-03-2021 13:18:12 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Usdan  Approved Jan-25-2021 21:28:15 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaUsdan, 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 Jan-25-2021 11:09:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Usdan  Approved Oct-22-2020 13:11:44 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903984
Page 126 of 259
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, LisaUsdan, 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.
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903985
Page 127 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
Aug-24-2020
11:08:13
(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
Aug-24-2020
11:08:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903986
Page 128 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020
11:08:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obt
ained
Aug/24/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903987
Page 129 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 11:08:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10371052Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 11:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
11:08:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020
11:08:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020
11:08:43
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903988
Page 130 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903989
Page 131 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020
11:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903990
Page 132 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
Aug-24-2020
11:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 11:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020
11:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903991
Page 133 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 14:03:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:OBESITY
Start Date: UNK/UNK
/2016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:03:46
(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
Aug-24-2020
14:03:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBESITYInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020
14:03:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903992
Page 134 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020
14:03:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-24-2020 14:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:SEASONAL
ALLERGIES
Start Date: UNK/UNK/19
97
Ongoing: YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903993
Page 135 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:04:11
(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
Aug-24-2020
14:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLERGIESInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020
14:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020
14:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-24-2020 14:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903994
Page 136 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical
History T
erm:GASTROESOPH
AGEAL REFLU
X DISEASE
Start Dat
e:UNK/UNK/2010
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:04:47
(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
Aug-24-2020
14:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHAGEAL
REFLUX DISEASEInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020
14:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020
14:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903995
Page 137 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d
Date Location User Value Reason
Aug-24-2020 14:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical Histor
y Term:ANXIETY
Start Date: UNK/UNK
/2016
Ongoing: YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903996
Page 138 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:05:08
(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
Aug-24-2020
14:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ANXIETYInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020
14:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020
14:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-24-2020 14:05:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903997
Page 139 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Hist
ory Term:BIPOLAR DE
PRESSION
Start Date: UNK/UNK/20
16
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:05:56
(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
Aug-24-2020
14:05:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BIPOLAR DEPRESSIONInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020
14:05:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020
14:05:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903998
Page 140 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f
Date Location User Value Reason
Aug-24-2020 14:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:UTERINE SC
ARRING
Start Date: UNK/UNK/20
11
Ongoing: NO
End Date:
UNK/UNK
/2017Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903999
Page 141 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:06:43
(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
Aug-24-2020
14:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UTERINE SCARRINGInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020
14:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020
14:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.g
Date Location User Value Reason
Aug-24-2020 14:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu 7Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904000
Page 142 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
mber:
Medical Histo
ry Term:HYSTEREC
TOMY
Start Date: UNK/UNK/2
017
Ongoing: NO
End Date:
UNK/UN
K/2017
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904001
Page 143 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020 14:07:12
(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
Aug-24-2020
14:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020
14:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020
14:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.h
Date Location User Value Reason
Mar-08-2021 14:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu 8Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904002
Page 144 of 259
***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, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
mber:
Medical Hist
ory Term:Exercise induc
ed Asthma
Start Date: UNK/UNK/20
19
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Mar-08-2021 14:46:21
(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
Mar-08-2021 14:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exercise induced AsthmaInitial Entry
1.h Start Date:
Date Location User Value Reason
Mar-08-2021 14:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Mar-08-2021 14:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904003
Page 145 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
83.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
162.6Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904004
Page 146 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020 14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.7Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.9
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
36.9Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904005
Page 147 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a Unit:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
14:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904006
Page 148 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904007
Page 149 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:Not D
one
Test:: Not D
one
Result:: Not D
one
Not Done:: Not D
oneInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904008
Page 150 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-24-2020
14:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904009
Page 151 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020
11:10:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020
11:10:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
63425Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904010
Page 152 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 11:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 11:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
11:56:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
11:56:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-24-2020
11:56:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904011
Page 153 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Aug-24-2020
11:56:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLBBMCInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
11:56:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLBBMCInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020
11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLBBMDInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020
11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLBBMDInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020
11:58:38
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5SB3Changed
Information
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904012
Page 154 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US &
Canada)
Aug-24-2020
11:57:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5SB3Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904013
Page 155 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
01:02:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
Aug-24-2020
11:58:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Aug-24-2020
11:58:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BN5SB3Changed
Information
Aug-24-2020
11:57:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Aug-24-2020
11:57:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Entered text has
either a carriage
return (line
break) or extra
spaces at the end
of the text or
between words.
Please correct by
removing all
data in the field
and re-enter
without adding
extra spaces or
using enter or
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0904014
Page 156 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
tab keys.
Aug-24-2020
11:57:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in
length. Please
review and
correct as
appropriate.
Aug-24-2020
11:57:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BN5SB3Initial Entry
5.d
Date Location User Value Reason
Aug-24-2020
11:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5SB4Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-24-2020
11:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SB4Initial Entry
5.e
Date Location User Value Reason
Aug-24-2020
11:59:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5SB5Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904015
Page 157 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Aug-24-2020
11:59:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SB5Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904016
Page 158 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 13:43:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 13:43:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
13:44:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
13:43:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-24-2020
13:43:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904017
Page 159 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Aug-24-2020
13:44:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5SB8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
13:44:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SB8Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904018
Page 160 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
Aug-24-2020
11:11:17 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 11:11:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 11:11:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020
11:11:17 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020 09:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 11:11:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904019
Page 161 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Side:
Date Location User Value Reason
Aug-24-2020
11:11:17 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020 11:11:17
(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
Aug-24-2020 11:11:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-24-2020
11:11:17 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904020
Page 162 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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-08-2020
02:42:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
Sep-02-2020
10:29:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-02-2020
10:29:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS
SUBJECTTranscription Error
Sep-02-2020
09:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-24-2020
11:11:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COLL
ECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0904021
Page 163 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020
01:24:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Closed Per site
confirmation-
FEVER NOT
COVID RELATED
THEREFORE NO
COVID ILLNESS
VISIT REQUIRED
Oct-22-2020
11:15:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answered PER
INVESTIGATOR,
FEVER NOT
COVID RELATED
THEREFORE NO
COVID ILLNESS
VISIT REQUIRED
Oct-22-2020
07:21:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Opened Illness eDiary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
08SEP2020. But
there is no COVID
Illness visit
reported in the
database.
Oct-09-2020
10:01:38
(UTC-06:00)ACV0PFEINFP6000  Query 2: Closed per response no
covid related.
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904022
Page 164 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
Oct-08-2020
06:53:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-07-2020
13:25:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered PER PI
CONVERSATION
WITH PATIENT,
AE NOT COVID
RELATED
THEREFORE, NO
COVID ILLNESS
VISIT
REPORTED.
Oct-07-2020
13:25:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered PER
INVESTIGATOR
CONVERSATION
WITH PATIENT,
AE NOT COVID
RELATED
THEREFORE, NO
COVID ILLNESS
VISIT
REPORTED.
Oct-07-2020
10:04:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
21SEP2020. But
there is no COVID
Illness visit
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904023
Page 165 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
reported in the
database. Please
clarify.
Oct-04-2020
03:26:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
03SEP2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Sep-14-2020
14:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904024
Page 166 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 36.7
Temperature
Unit:C
Temperature
Location::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904025
Page 167 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 14:03:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904026
Page 168 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904027
Page 169 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:Not D
one
Test:: Not D
one
Result:: Not D
one
Not Done:: Not D
oneInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904028
Page 170 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-15-2020 08:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904029
Page 171 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 14:59:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 14:59:51
(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-14-2020
15:00:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-14-2020
14:59:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-14-2020
14:59:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904030
Page 172 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-14-2020
15:00:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP7HV3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020
15:00:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP7HV3Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904031
Page 173 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 14:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904032
Page 174 of 259
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-14-2020 15:21:09
(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
Sep-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION 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-14-2020 15:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904033
Page 175 of 259
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020
10:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904034
Page 176 of 259
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 10:33:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 10:33:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
10:33:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
10:33:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-12-2020
10:33:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904035
Page 177 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-12-2020
10:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BK6YM8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
10:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BK6YM8Initial Entry
5.b
Date Location User Value Reason
Oct-12-2020
10:34:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLBB99Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
10:34:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLBB99Initial Entry
5.c
Date Location User Value Reason
Oct-12-2020
10:34:15
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BKP236Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904036
Page 178 of 259
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
10:34:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKP236Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904037
Page 179 of 259
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
09:43:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904038
Page 180 of 259
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 13:36:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 13:36:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
13:36:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
13:36:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Mar-10-2021
13:36:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904039
Page 181 of 259
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Mar-10-2021
13:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSNF3Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
13:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRSNF3Initial Entry
5.b
Date Location User Value Reason
Mar-10-2021
13:37:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6MHHInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
13:37:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS6MHHInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
13:37:54
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BRJPNLInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904040
Page 182 of 259
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
13:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRJPNLInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904041
Page 183 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
06:39:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 5: Opened DM: Kindly
review and
complete
‘Hospitalization
Details' at this
visit. Thank you.
Mar-03-2021
01:47:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 4: Closed Closed,
Convalescent visit
updated.
Mar-02-2021
14:39:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 4: Answered Data entered, visit
within window
Feb-25-2021
05:09:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 4: Opened PDQ:
Convalescent visit
is missing and 35
days (36) have
passed since
COVID Illness
Visit. If visit
occurred record
data as a matching
CONVA visit; if
visit did not occur
attempt to
schedule visit
even if OOW and
obtain the
CONVA sample
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904042
Page 184 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
else clarify.
Feb-04-2021
15:06:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-04-2021
09:14:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription
Error
Feb-04-2021
09:14:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Transcription
Error
Feb-04-2021
09:12:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-27-2021
07:39:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete ‘Health
Care Utilization,
Microbiology
Specimen, Illness
Details form' at
this visit. Thank
you.
Jan-26-2021
10:33:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened DM: Date of Visit
is completed but
Date of
Assessment in the
Signs and
Symptoms form is
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904043
Page 185 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
missing. Please
review and update
as appropriate.
Jan-25-2021
11:11:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-25-2021
11:09:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-25-2021
11:09:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Jan-25-2021
11:09:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-25-2021 11:09:02
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904044
Page 186 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904045
Page 187 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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-04-2021
09:14:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-04-2021
09:12:29
(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-04-2021
09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-22-2021
08:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-19-2021
10:36:35ACV0PFEINFP6000  Query 1: Answered yes still ongoing
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904046
Page 188 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)
Feb-08-2021
13:06:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please clarify
whether the
reported
symptoms are still
ongoing? If
symptoms have
ended, please
update
‘Symptoms
Ongoing’ on to
‘NO’ and add
Date of Last
Symptom
Resolved on the
CRF.
Feb-04-2021
09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Present
:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904047
Page 189 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.a Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED COUG
H
Sympto
m Presen
t:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED C
OUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
SymptNEW OR INCREInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904048
Page 190 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) oms:ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:YES
4.c Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Presen
t:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904049
Page 191 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED MUSCL
E PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904050
Page 192 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.e Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SM
ELL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904051
Page 193 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE O
R SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCR
EASED SORE T
HROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904052
Page 194 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904053
Page 195 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-04-2021 09:12:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Mar-03-2021
14:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms - Ot
her:INCREASED S
EASONAL AL
LERGIESTranscription
Error
Feb-04-2021
09:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s - Other:SEASONAL
ALLERGIESInitial Entry
5.a Symptoms - Other Text:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904054
Page 196 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-09-2021
07:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-08-2021
14:26:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI, will leave
increased seasonal
allergies
Mar-03-2021
14:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dCLINQUERY:
Please confirm -
is INCREASED
SEASONAL
ALLERGIES a
diagnosis? Only
SIGNS or
SYMPTOMS of
potential
COVID-19 are
entered
here.Please
confirm or else
clarify.
Mar-03-2021
14:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Mar-03-2021
14:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
INCREASED SEASON
AL ALLERGIESTranscription
Error
Mar-01-2021
17:35:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Only SIGNS or
SYMPTOMS of
potential
COVID-19 are
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904055
Page 197 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
entered here.
Please review
term of 'Seasonal
Allergies'. Is this
a diagnosis? All
diagnoses are
entered on the
COV ILL
ILLNESS
DETAILS CRF.
Please review and
update data as
appropriate
Mar-01-2021
17:23:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Only SIGNS or
SYMPTOMS of
potential
COVID-19 are
entered here.
Please review
term of 'Seasonal
Allergies'. Is this
a diagnosis? All
diagnoses are
entered on the
COV ILL
ILLNESS
DETAILS CRF.
Please review and
update data as
appropriate
Feb-04-2021
09:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLERGI
ESInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904056
Page 198 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904057
Page 199 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC
TESTInitial Entry
6. Trade Name:
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904058
Page 200 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-04-2021 09:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UNKNOWNInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904059
Page 201 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: 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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 11:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 11:11:42
(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
Jan-25-2021
11:11:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
11:11:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-25-2021
11:11:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904060
Page 202 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: 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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Jan-25-2021
11:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV06550Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
11:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV06550Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904061
Page 203 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 11:12:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 11:12:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021
11:12:45
(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:
Date Location User Value Reason
Jan-25-2021
11:12:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 
)Data Entry:
due to self swab collectio
n no office swab was co
mpletedInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904062
Page 204 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:SPECI
ALIST
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OM
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904063
Page 205 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-04-2021
09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence
of Visits or
Contacts:YES
Number of
Visits or Co
ntacts:
1Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904064
Page 206 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSIC
IANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Conta
cts:
1Initial Entry
1.d
Date Location User Value Reason
Feb-04-2021
09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:URGENT C
ARE
Occurrence
of Visits or
Contacts:YES
Number of
Visits or Co
ntacts:
1Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904065
Page 207 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Conta
cts:
1Initial Entry
1.e
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:TELEPHON
E CONSUL
TATION
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904066
Page 208 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTA
TIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:OTH
ER
Occurrence of Visit
s or Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-04-2021 09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904067
Page 209 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-12-2021
07:46:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY:
Subject was
hospitalized.
Please enter on the
relevant CRF form
any available
information (vital
signs, pulse
oxymet,
respiratory
treatment, lab
results,
imaging…).
Please make every
effort to obtain
this information.
Mar-12-2021
07:45:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Re-issued
Mar-12-2021
07:45:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dCLINQUERY:
Subject had
COVID-19 Illness
and was
hospitalized.
Please enter on the
relevant CRF form
any available
information (vital
signs, pulse
oxymet,
respiratory
treatment, lab
results,
imaging…).
Please make every
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904068
Page 210 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
effort to obtain
this information.
Mar-11-2021
13:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Mar-11-2021
13:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in i
ntensive care due to pote
ntial COVID-19 illness?
NOChanged
Information
Mar-11-2021
10:35:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dCLINQUERY: Per
AE CRF, AE of
Shortness of
Breath from
Nov2020 was
serious and led to
hospitalization.
But here, Has the
subject been
hospitalized =
NO. Please review
and update field
here per data or
else clarify.
Mar-11-2021
10:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Query is
ambiguous
Mar-11-2021
00:04:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Per
AE Log, event of
SOB in Nov2020
led to
hospitalization.
Please update data
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904069
Page 211 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
in response to this
question or else
clarify.
Mar-10-2021
12:12:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY: Per
AE Log, event of
SOB in Nov2020
led to
hospitalization.
Please update data
in response to this
question or else
clarify.
Feb-04-2021
09:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904070
Page 212 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/20/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-04-2021 09:27:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILL
NESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-04-2021 09:27:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-04-2021 09:27:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904071
Page 213 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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-25-2021
13:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-25-2021
13:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904072
Page 214 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 13:27:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 13:27:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021
13:27:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-25-2021
13:27:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
13:27:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904073
Page 215 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Feb-25-2021
13:27:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6MG0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-25-2021
13:27:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS6MG0Initial Entry
5.b
Date Location User Value Reason
Feb-25-2021
13:28:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSNCLInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-25-2021
13:28:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRSNCLInitial Entry
5.c
Date Location User Value Reason
Feb-25-2021
13:28:36
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BRJPM3Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904074
Page 216 of 259
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Feb-25-2021
13:28:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRJPM3Initial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904075
Page 217 of 259
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 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
Oct-12-2020 14:47:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 14:47:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 14:47:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904076
Page 218 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904077
Page 219 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-08-2020 09:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904078
Page 220 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-08-2020 09:17:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904079
Page 221 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-15-2020 13:24:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904080
Page 222 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-03-2021 13:18:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904081
Page 223 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FLU LIKE SYMPTOMSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/20/2020 UNK:UNKInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904082
Page 224 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904083
Page 225 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020
13:22:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed site updated
Oct-21-2020
09:01:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-21-2020
09:01:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DTranscription
Error
Oct-17-2020
16:19:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Recovered, no
sequelae per AE
Log in source,
verify.
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904084
Page 226 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
D WITH SEQUELAEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-08-2020 08:58:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d46\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904085
Page 227 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-08-2020 09:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-08-2020 09:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individ
…[truncated]