125742 S1 M5 CRF c4591001 1136 11361082

Document text

Page 1 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982302
Page 2 of 224
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/27/2020
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982303
Page 3 of 224
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11361082]
2.Birth Date: /1989
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:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982304
Page 4 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982305
Page 5 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982306
Page 6 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982307
Page 7 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral inguinal hernia]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[iodine allergy]
Start Date: UNK/UNK/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[shellfish allergy]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral inguinal hernia repair]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982308
Page 8 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[C-section]
Start Date: Apr/19/2019
Ongoing: NO
End Date:
Apr/19/2019
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982309
Page 9 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982310
Page 10 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [125.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [21.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982311
Page 11 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982312
Page 12 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [114248]
3.Randomization Group: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982313
Page 13 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BM91TK]
5.bSample ID [BM91TJ]
5.cSample ID [BM91TL]
5.dSample ID [BPRSN6]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982314
Page 14 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BM91T6]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982315
Page 15 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Oct/27/2020 14:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982316
Page 16 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982317
Page 17 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982318
Page 18 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982319
Page 19 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982320
Page 20 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFWWH]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982321
Page 21 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Nov/19/2020 09:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982322
Page 22 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982323
Page 23 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
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 [BRFX1K]
5.bSample ID [BRFX1L]
5.cSample ID [BRFX1M]
5.dSample ID [BPRSTH]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982324
Page 24 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982325
Page 25 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982326
Page 26 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982327
Page 27 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982328
Page 28 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982329
Page 29 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982330
Page 30 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982331
Page 31 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/14/2021
2.Date of First Symptom Started: Jan/13/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982332
Page 32 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.Symptoms - Other Text: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982333
Page 33 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982334
Page 34 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982335
Page 35 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Nasal swab self not collected. Swab PFE collected and entered in SWAB PFE.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982336
Page 36 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BRFX3Y]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982337
Page 37 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982338
Page 38 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982339
Page 39 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982340
Page 40 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982341
Page 41 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982342
Page 42 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982343
Page 43 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982344
Page 44 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982345
Page 45 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982346
Page 46 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982347
Page 47 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
 1.Jan/14/2021 Record Identifier: Systolic: Diastolic:
1  130  79 Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982348
Page 48 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/14/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [130]
Diastolic: [79]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [74]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982349
Page 49 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
 1.Jan/14/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982350
Page 50 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/14/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982351
Page 51 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982352
Page 52 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982353
Page 53 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982354
Page 54 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982355
Page 55 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982356
Page 56 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982357
Page 57 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982358
Page 58 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982359
Page 59 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982360
Page 60 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982361
Page 61 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  EXPOSURE DURING PR
EGNANCY Dec/1/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982362
Page 62 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Dec/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982363
Page 63 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982364
Page 64 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982365
Page 65 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982366
Page 66 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982367
Page 67 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: //
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982368
Page 68 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982369
Page 69 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982370
Page 70 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982371
Page 71 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982372
Page 72 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982373
Page 73 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982374
Page 74 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982375
Page 75 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982376
Page 76 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982377
Page 77 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982378
Page 78 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982379
Page 79 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982380
Page 80 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982381
Page 81 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982382
Page 82 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982383
Page 83 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982384
Page 84 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982385
Page 85 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982386
Page 86 of 224
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982387
Page 87 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982388
Page 88 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982389
Page 89 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982390
Page 90 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982391
Page 91 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982392
Page 92 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982393
Page 93 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982394
Page 94 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Applicable Comments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982395
Page 95 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Done
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982396
Page 96 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982397
Page 97 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]Comments
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982398
Page 98 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/18/2020
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982399
Page 99 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982400
Page 100 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982401
Page 101 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-30-2020 11:44:46 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982402
Page 102 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-22-2021 10:44:39 (UTC-08:00) Pacific
Time (US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982403
Page 103 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982404
Page 104 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982405
Page 105 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982406
Page 106 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982407
Page 107 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982408
Page 108 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982409
Page 109 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982410
Page 110 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982411
Page 111 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Feb-22-2021 10:44:39 (UTC-08:00) Pacific Time
(US & Canada)Swab was done in office
Not Done
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982412
Page 112 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-15-2021 12:49:42 (UTC-08:00) Pacific
Time (US & Canada)Nasal swab SELF not collected. Nasal swab
PFE collected and entered in NASAL SWAB
PFE.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982413
Page 113 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-22-2021 09:56:44 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982414
Page 114 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-22-2021 09:56:44 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982415
Page 115 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-22-2021 09:57:05 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982416
Page 116 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-22-2021 09:57:05 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982417
Page 117 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-15-2021 12:04:25 (UTC-08:00) Pacific
Time (US & Canada)Illness Visit on 14JAN2021. Mistakenly entered
as V101.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982418
Page 118 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 11:25:55 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982419
Page 119 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 11:25:55 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982420
Page 120 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-15-2021 12:04:59 (UTC-08:00) Pacific
Time (US & Canada)Not Done
FormJan-14-2021 13:44:49 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982421
Page 121 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 11:26:57 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
FormJan-15-2021 12:05:51 (UTC-08:00) Pacific
Time (US & Canada)Illness visit done on 14JAN2021. Mistakenly
entered as V101.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982422
Page 122 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 11:26:57 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982423
Page 123 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Jan-21-2021 11:26:57 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982424
Page 124 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-21-2021 11:26:57 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982425
Page 125 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Jan-21-2021 11:26:57 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982426
Page 126 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-22-2021 11:02:27 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
FormJan-15-2021 12:03:06 (UTC-08:00) Pacific
Time (US & Canada)Illness visit on 14JAN2021, not V101.
Mistakenly entered as V101. Date of visit and
nasal swab bar code mistakenly entered as
V101.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982427
Page 127 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-22-2021 11:02:27 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982428
Page 128 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Jan-22-2021 11:02:27 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982429
Page 129 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-22-2021 11:02:27 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982430
Page 130 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Jan-22-2021 11:02:27 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982431
Page 131 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aJan-15-2021 12:44:28 (UTC-08:00) Pacific Time
(US & Canada)Nasal swab done at Illness Visit on 14JAN2021.
Mistakenly entered as occurring at V101. Bar
code for nasal swab entered in Illness Visit.
Not Done
5.aJan-15-2021 12:09:27 (UTC-08:00) Pacific Time
(US & Canada)Nasal swab bar code mistakenly entered as
occurring on 14JAN2021. Subj had Illness Visit
on 14JAN2021 were in Nasal swab bar code will
be entered.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982432
Page 132 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982433
Page 133 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-30-2020 11:01:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-30-2020 11:01:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982434
Page 134 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-30-2020 11:03:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/27/2020Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982435
Page 135 of 224
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-30-2020 11:01:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11361082Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020 11:01:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-04-2020
04:45:37
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: C
losedResponse
satisfies query
Nov-02-2020
08:20:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription
Error
Nov-02-2020
08:20:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
FEMALETranscription
Error
Nov-01-2020
23:52:26
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: O
penedAs per Impala,
Sex is recorded
as Female.
Please review
and update as
appropriate.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982436
Page 136 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-30-2020
11:04:10
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-30-2020 11:04:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-30-2020 11:04:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982437
Page 137 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 11:05:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982438
Page 138 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-30-2020 11:06:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 11:06:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 11:06:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982439
Page 139 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Oct-30-2020 11:16:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:bilateral inguinal
hernia
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1
998Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-30-2020 11:16:12
(UTC-08:00) Pacific 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
Oct-30-2020 11:16:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
bilateral inguinal herniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-30-2020 11:16:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-30-2020 11:16:12 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982440
Page 140 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-08:00) Pacific
Time (US & Canada)NO
End Date:
UNK/UNK/1998
1.b
Date Location User Value Reason
Oct-30-2020 11:17:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:iodine allergy
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-30-2020 11:17:09
(UTC-08:00) Pacific 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
Oct-30-2020 11:17:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
iodine allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-30-2020 11:17:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-30-2020 11:17:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982441
Page 141 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c
Date Location User Value Reason
Oct-30-2020 11:18:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:shellfish aller
gy
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-30-2020 11:18:08
(UTC-08:00) Pacific 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
Oct-30-2020 11:18:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
shellfish allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-30-2020 11:18:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-30-2020 11:18:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982442
Page 142 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-30-2020 11:19:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:bilateral inguinal h
ernia repair
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/199
8Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Oct-30-2020 11:19:52
(UTC-08:00) Pacific 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
Oct-30-2020 11:19:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
bilateral inguinal hernia repairInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-30-2020 11:19:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-30-2020 11:19:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.e
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982443
Page 143 of 224
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-30-2020 11:21:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:C-section
Start Date: Apr/19/2019
Ongoing: NO
End Date:
Apr/19/20
19Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-30-2020 11:21:02
(UTC-08:00) Pacific 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
Oct-30-2020 11:21:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
C-sectionInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-30-2020 11:21:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/19/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-30-2020 11:21:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/19/2019Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982444
Page 144 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-30-2020 11:06:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982445
Page 145 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
125.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.5Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982446
Page 146 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020 11:08:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982447
Page 147 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-02-2020 08:22:52
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982448
Page 148 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::
Nov-02-2020 08:22:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: POSITIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-02-2020 08:22:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-02-2020 08:22:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 08:22:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVETranscription Error
Nov-02-2020 08:22:28 ACV0PFEINFP6000  auto query Query 1: Opened Lab result is
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982449
Page 149 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-08:00) Pacific
Time (US & Canada)(autoquery) “Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
Nov-02-2020 08:22:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982450
Page 150 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-30-2020 11:09:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020 11:09:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
114248Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982451
Page 151 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 11:09:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 11:09:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 08:20:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 02:52:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 11:09:46
(UTC-08:00) Pacific
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-30-2020 11:09:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982452
Page 152 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-02-2020 08:20:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM91TKInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 08:20:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM91TKInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 08:20:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM91TJInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 08:20:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM91TJInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 08:21:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM91TLInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 08:21:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM91TLInitial Entry
5.d
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982453
Page 153 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Jan-22-2021 10:58:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRSN6Initial Entry
5.d Sample ID
Date Location User Value Reason
Jan-22-2021 10:58:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRSN6Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982454
Page 154 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 11:10:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 11:10:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 08:21:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 02:52:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 11:10:05
(UTC-08:00) Pacific
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-30-2020 11:10:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982455
Page 155 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-02-2020 08:21:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM91T6Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 08:21:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM91T6Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982456
Page 156 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020 14:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982457
Page 157 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-30-2020 11:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982458
Page 158 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-30-2020 11:11:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982459
Page 159 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-20-2020 09:38:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982460
Page 160 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982461
Page 161 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-20-2020 09:39:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982462
Page 162 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982463
Page 163 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-20-2020 09:39:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982464
Page 164 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-20-2020 09:40:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-20-2020 09:40:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-20-2020 09:57:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 09:40:02
(UTC-08:00) Pacific
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.
Nov-20-2020 09:40:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020 09:45:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFWWHTranscription Error
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982465
Page 165 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-20-2020 09:57:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFWWLInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
12:52:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_06
Nov-24-2020
09:45:27
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Nov-24-2020
09:45:27
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
BRFW
WHTranscription Error
Nov-22-2020
22:05:13
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5441241;The
barcode BRFWWL is
recorded for two
subjects 11361082
and 11361102, please
review and update as
appropriate.
Nov-20-2020
09:57:44
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
BRFW
WLInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982466
Page 166 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020 09:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982467
Page 167 of 224
***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, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-20-2020 09:41:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982468
Page 168 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 10:23:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982469
Page 169 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 10:23:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 10:23:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 10:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 10:23:36
(UTC-08:00) Pacific
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.
Dec-18-2020 10:23:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 10:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFX1KInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982470
Page 170 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 10:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFX1KInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 10:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFX1LInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 10:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFX1LInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 10:48:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFX1MInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 10:48:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFX1MInitial Entry
5.d
Date Location User Value Reason
Dec-22-2020 11:49:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRSTHInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982471
Page 171 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Dec-22-2020 11:49:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRSTHInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982472
Page 172 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 23:25:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Per site
confirmation_PD
tracker updated
Mar-08-2021 12:08:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Convalescent visit
was not done due to
site error.
Mar-02-2021 03:03:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened PDQ RQ1: No data
changed. please
confirm whether
subject was
contacted for
CONVA visit and
accordingly, enter
CONVA visit details,
else confirm planned
CONVA visit date.
Mar-01-2021 10:59:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Transcription Error
Mar-01-2021 10:58:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Changed Information
Mar-01-2021 10:58:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Changed Information
Feb-22-2021 23:13:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-22-2021 10:45:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Data has been
completed
Feb-19-2021 02:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened PDQ: Convalescent
visit is missing and
35 days (36) have
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982473
Page 173 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
else clarify.
Jan-20-2021 07:32:17
(UTC-08:00) Pacific
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-15-2021 12:23:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-15-2021 12:13:20
(UTC-08:00) Pacific
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-15-2021 12:13:20
(UTC-08:00) Pacific
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-15-2021 12:13:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982474
Page 174 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-15-2021 12:13:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982475
Page 175 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-01-2021 10:59:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:58:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of assessment
is not same as Date
Visit. Please check
and correct.
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982476
Page 176 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982477
Page 177 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sympto
m Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982478
Page 178 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982479
Page 179 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.g
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982480
Page 180 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.h Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: YESInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-15-2021 12:22:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982481
Page 181 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982482
Page 182 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Test Result:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-22-2021 10:44:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982483
Page 183 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: 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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 12:30:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 12:30:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 12:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Jan-15-2021 12:46:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update as
appropriate.
Jan-15-2021 12:46:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-15-2021 12:46:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Jan-15-2021 12:45:47
(UTC-08:00) PacificACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate 'Sample Collected?'
is Yes, however no
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982484
Page 184 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: 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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) barcodes are entered.
Please review and
correct as
appropriate.
Jan-15-2021 12:45:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:45:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/14/2021Transcription Error
Jan-15-2021 12:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update as
appropriate.
Jan-15-2021 12:30:18
(UTC-08:00) Pacific
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-15-2021 12:48:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:48:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nasal swab self not collected. Swa
b PFE collected and entered in SW
AB PFE.Transcription Error
Jan-15-2021 12:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break) or
extra spaces at the
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982485
Page 185 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: 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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 tab keys.
Jan-15-2021 12:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nasal swab self not collected. Swa
b PFE collected and entered in SW
AB PFE.Initial Entry
5.a
Date Location User Value Reason
Jan-15-2021 12:29:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Jan-15-2021 12:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFX3YInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 12:29:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:29:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-15-2021 12:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not 7
characters in length.
Please review and
correct as
appropriate.
Jan-15-2021 12:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFX3YInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982486
Page 186 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 12:23:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 12:23:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021 10:59:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-01-2021 10:58:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection
14/Jan/2021 is
different from Date
of Visit 08/Dec
/2020. Please review
and update as
appropriate, else
clarify.
Jan-15-2021 12:28:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 12:23:05
(UTC-08:00) Pacific
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-15-2021 12:23:05
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982487
Page 187 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Jan/14/2021
5.a
Date Location User Value Reason
Jan-15-2021 12:28:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFX3YInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 12:28:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFX3YInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982488
Page 188 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982489
Page 189 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982490
Page 190 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982491
Page 191 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-22-2021 10:43:24
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982492
Page 192 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982493
Page 193 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-22-2021 10:44:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-22-2021 10:44:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-22-2021 10:44:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982494
Page 194 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 10-Oct-2020 15:59 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982495
Page 195 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2.a
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Systolic:: 13
0
Diastolic:: 79
Respiratory Rate in respirat
ions/minute:18
Heart Rate in beats/minute: 74Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
130Initial Entry
2.a Diastolic:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
79Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982496
Page 196 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
18Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Jan-15-2021 12:36:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
74Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982497
Page 197 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit Trail
Form Version: 10-Oct-2020 16:04 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-15-2021 12:36:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982498
Page 198 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-15-2021 12:36:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2.a
Date Location User Value Reason
Jan-15-2021 12:36:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Oxygen Saturation: 99.0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-15-2021 12:36:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Jan-15-2021 12:36:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.0Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982499
Page 199 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982500
Page 200 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific 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
Mar-03-2021 11:24:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-03-2021 08:27:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirmed, follow
up SAE form was
faxed to Safety
database.
Mar-02-2021 00:57:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON:
Please confirm if
follow up SAE form
was sent to update
term in Safety
database.
Mar-01-2021 11:00:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Mar-01-2021 11:00:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EXPOSURE DURING PREGN
ANCYChanged
Information
Feb-23-2021 10:10:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Per
CRF Guidelines
8.50.2.5. Specific
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982501
Page 201 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Guidance for
Pregnancy - the AE
Term should be
EXOSURE
DURING
PREGNANCY.
Please update
accordingly.
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 14:22:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/1/2020 UNK:UNKChanged Information
Mar-08-2021 00:11:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed SDB onset date updated
Mar-04-2021 01:44:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-03-2021 08:28:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirmed, follow up was
faxed to Safety database.
Mar-02-2021 00:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: Please
confirm if follow up AEM
for was sent to update onset
date in Safety database
Mar-01-2021 11:00:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Mar-01-2021 11:00:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020 UNK:UNKChanged Information
Feb-25-2021 22:10:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021046308
As per V12 CRF CG
8.50.2.5, Date of onset is
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982502
Page 202 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
determined by ultrasound
results or date of last
menstrual period. Per
report, the LPM is
08Dec2020.Please confirm
and update AE CRF and
Safety database
accordingly.
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Mar-02-2021 03:13:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Mar-01-2021 11:01:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Mar-01-2021 11:01:21
(UTC-08:00) PacificACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982503
Page 203 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Mar-01-2021 11:01:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Mar-01-2021 11:00:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate For AE EXPOSURE
DURING PREGNANCY:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-24-2021 01:11:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be addressed
internally
Feb-22-2021 14:27:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021146306
Non serious AE of
PREGNANCY was
reported in Safety database
but reported as serious in
AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE PREGNANCY:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requi
re or prolong hospitalizatioInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982504
Page 204 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
n?
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
PregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982505
Page 205 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 00:51:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-01-2021 23:11:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-01-2021 11:13:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Condition is still
ongoing
Mar-01-2021 11:01:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Mar-01-2021 11:01:44 ACV0PFEINFP6000  auto query Query 1: Answered Changed Information
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0982506
Page 206 of 224
***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
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-08:00) Pacific
Time (US & Canada)(autoquery)
Mar-01-2021 11:01:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNChanged Information
Feb-24-2021 01:13:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021046308,
the outcome in AE
CRF was reported as
NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance ,
outcome should be
recorded as
UNKNOWN. Please
confirm and update
accordingly.
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 10:47:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982507
Page 207 of 224
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-18-2020 10:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 10:24:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 10:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982508
Page 208 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 13:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982509
Page 209 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 10:20:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
Jan-15-2021 12:52:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:52:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-14-2021 20:43:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-14-2021 13:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-14-2021 13:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982510
Page 210 of 224
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982511
Page 211 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021 09:56:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-08-2021
19:44:48
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Mar-08-2021
10:21:00
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per query
Mar-08-2021
03:24:37
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: Primary Reason
for Unblinding is
"ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Mar-05-2021
12:30:37
(UTC-08:00)
Pacific Time
(US &ACV0PFEINFP6000  Query
1: An
swere
dThe subject received
active IP during study
participation and thus
is not eligible to return
for vaccination.
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982512
Page 212 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Canada)
Feb-22-2021
11:49:00
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7350241;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-22-2021
09:56:30
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982513
Page 213 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-22-2021 09:56:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982514
Page 214 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-22-2021 09:57:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982515
Page 215 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-24-2021 21:34:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 11:02:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-21-2021 20:32:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM : visit is
marked as
Erroneous visit.
However, data is
present on SWAB
PFE CRF. Please
review and add
form level comment
as Not Applicable.
Else, clarify.
Jan-21-2021 11:27:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-18-2021 04:32:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Jan-15-2021 12:09:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982516
Page 216 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Jan-14-2021 13:44:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-15-2021 12:09:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982517
Page 217 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-21-2021 11:25:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982518
Page 218 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-21-2021 11:26:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-15-2021 12:10:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-14-2021 13:45:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-21-2021 11:26:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-15-2021 12:10:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-14-2021 13:45:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-21-2021 11:26:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 11:26:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Jan-15-2021 12:12:07
(UTC-08:00) PacificACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982519
Page 219 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Jan-15-2021 12:11:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is OTHER but
"Specify Status" is
missing.
Jan-15-2021 12:11:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERTranscription Error
Jan-14-2021 13:45:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Jan-21-2021 11:26:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 11:26:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Jan-15-2021 12:12:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Illness Visit occurred on 14JAN2
021, but mistakenly entered as V1
01.Initial Entry
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982520
Page 220 of 224
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021 11:02:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 11:01:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-14-2021 13:45:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021 11:02:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 11:01:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-14-2021 13:45:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 11:02:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-22-2021 11:01:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-15-2021 12:41:36
(UTC-08:00) PacificACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae3f0c\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982521
Page 221 of 224
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361082 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Jan-15-2021 12:07:37
(UTC
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