Document text
Page 1 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943325
Page 2 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/21/2020
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943326
Page 3 of 203
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521551]
2.Birth Date: /1970
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943327
Page 4 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943328
Page 5 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943329
Page 6 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943330
Page 7 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pneumonia]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thyroid cancer]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Caesarean section]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943331
Page 8 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Caesarean section]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[uterine fibroids]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[myomectomy]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cosmetic rhinoplasty]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943332
Page 9 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[incisional hernia]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[incisional hernia repair]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[femoral hernia]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[femoral hernia repair]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943333
Page 10 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia repair]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thyroidectomy]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign right breast papilloma]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943334
Page 11 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right breast duct excision]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[II/VI systolic ejection heart murmur diagnosed]
Start Date: Oct/21/2020
Ongoing: YES
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943335
Page 12 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943336
Page 13 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
2.Weight: [178.0]
3.Unit: LB
4.Height: [62.25]
5.Unit: in
6.Body Mass Index: [32.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943337
Page 14 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/21/2020
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943338
Page 15 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/21/2020
2.Randomization Number: [111199]
3.Randomization Group: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943339
Page 16 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BRJGJN]
5.bSample ID [BRJGJP]
5.cSample ID [BS6JX5]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943340
Page 17 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BR921W]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943341
Page 18 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/21/2020 12:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943342
Page 19 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943343
Page 20 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943344
Page 21 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943345
Page 22 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/11/2020
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943346
Page 23 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9259]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943347
Page 24 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/11/2020 10:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943348
Page 25 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943349
Page 26 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJNCY]
5.bSample ID [BRJNCZ]
5.cSample ID [BS6K8K]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943350
Page 27 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943351
Page 28 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943352
Page 29 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943353
Page 30 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943354
Page 31 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943355
Page 32 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943356
Page 33 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943357
Page 34 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943358
Page 35 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943359
Page 36 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943360
Page 37 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Fever (101.9 F) Oct/21/2020 22:0
0 NO
End Date Time:
Oct/24/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Fatigue Oct/22/2020 10:0
0 NO
End Date Time:
Oct/22/2020 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 Left Ear Pain Jan/22/2021 UN
K:UNK YES Repeating
Pages
4.ADVERSE E
VENT 4 Swollen Lymph Nodes (
Left Jaw) Jan/22/2021 UN
K:UNK YES Repeating
Pages
5.ADVERSE E
VENT 5 Swollen Lymph Nodes (
Left Neck) Jan/22/2021 UN
K:UNK YES Repeating
Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943361
Page 38 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Fever (101.9 F)]
4.Start Date Time: Oct/21/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/24/2020 UNK:UNK
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943362
Page 39 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943363
Page 40 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Oct/22/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/22/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943364
Page 41 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943365
Page 42 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Ear Pain]
4.Start Date Time: Jan/22/2021 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:
[Unknown - Possible Infection (ENT Consult Pending)]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943366
Page 43 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943367
Page 44 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Swollen Lymph Nodes (Left Jaw)]
4.Start Date Time: Jan/22/2021 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:
[Unknown - Possible Infection (ENT Consult Pending)]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943368
Page 45 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943369
Page 46 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Swollen Lymph Nodes (Left Neck)]
4.Start Date Time: Jan/22/2021 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:
[Unknown - Possible Infection (ENT Consult Pending)]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943370
Page 47 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943371
Page 48 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943372
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943373
Page 50 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943374
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***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: //
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943375
Page 52 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943376
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943377
Page 54 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943378
Page 55 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943379
Page 56 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943380
Page 57 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943381
Page 58 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943382
Page 59 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943383
Page 60 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943384
Page 61 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943385
Page 62 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943386
Page 63 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943387
Page 64 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943388
Page 65 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943389
Page 66 of 203
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943390
Page 67 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943391
Page 68 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943392
Page 69 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943393
Page 70 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943394
Page 71 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943395
Page 72 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943396
Page 73 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943397
Page 74 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/18/2020
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943398
Page 75 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [BRGVRD]
5.bSample ID [BRGVRF]
5.cSample ID [BS6KCW]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943399
Page 76 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BRRKXJ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943400
Page 77 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 08:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943401
Page 78 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943402
Page 79 of 203
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943403
Page 80 of 203
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943404
Page 81 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943405
Page 82 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/8/2021
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:
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943406
Page 83 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BRRL3H]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943407
Page 84 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/8/2021 08:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943408
Page 85 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943409
Page 86 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/10/2021
3.Comments: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943410
Page 87 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943411
Page 88 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943412
Page 89 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943413
Page 90 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943414
Page 91 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943415
Page 92 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/9/2020
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943416
Page 93 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943417
Page 94 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943418
Page 95 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormOct-21-2020 14:03:02 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943419
Page 96 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormDec-18-2020 10:35:03 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943420
Page 97 of 203
***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, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-10-2021 17:27:40 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Jan-21-2021 13:41:24 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943421
Page 98 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-21-2020 14:02:11
(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-21-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943422
Page 99 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020 14:02:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/21/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943423
Page 100 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020 14:01:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11521551Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020 14:01:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-21-2020 14:02:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020 14:02:41
(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-21-2020 14:02:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943424
Page 101 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-20-2020 01:22:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-19-2020 12:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered THESE
SYMPTOMS
WERE DURING
THE 7 DAYS
FOLLOWING
VACCINATION.
SUBJECT IS NOT
IN THE SUB
GROUP
THEREFORE, PER
PROTOCOL,
THESE ARE ASs
Nov-18-2020 22:20:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Response
states 'report was for
symptoms that stared
on 22 Oct 2020. See
AE Log'. Please
confirm if Illness
ediary entry on
28OCT2020 was
deemed erroneous
and that subject had
no Covid Illness
symptoms.
Nov-18-2020 17:57:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The report was for
symptoms that stared
on 22 Oct 2020. See
AE Log.
Nov-17-2020 18:38:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced any
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943425
Page 102 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
of the following?”
for the COVID-19
symptoms or
diagnosis on
28OCT2020. But
there is no COVID
Illness visit reported
in the database.
Oct-21-2020 14:02:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943426
Page 103 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020 14:03:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 14:03:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 14:03:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943427
Page 104 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 14:03:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:pneumonia
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:03:41
(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-21-2020 14:03:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pneumoniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-21-2020 14:03:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943428
Page 105 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:03:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Oct-21-2020 14:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:thyroid cancer
Start Date: UNK/UNK/201
0
Ongoing: NO
End Date:
UNK/UNK/
2010Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943429
Page 106 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:04:03
(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-21-2020 14:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
thyroid cancerInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-21-2020 14:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-21-2020 14:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.c
Date Location User Value Reason
Oct-21-2020 14:04:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Caesarean secti
on
Start Date: UNK/UNK/200
6Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943430
Page 107 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/
2006
1.c Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:04:43
(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-21-2020 14:04:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Caesarean sectionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-21-2020 14:04:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-21-2020 14:04:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.d
Date Location User Value Reason
Oct-21-2020 14:04:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943431
Page 108 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical History
Term:Caesarean secti
on
Start Date: UNK/UNK/200
9
Ongoing: NO
End Date:
UNK/UNK/
2009
1.d Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:04:59
(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-21-2020 14:04:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Caesarean sectionInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-21-2020 14:04:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-21-2020 14:04:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.e
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943432
Page 109 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:05:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:uterine fibroids
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/
2004Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:05:25
(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-21-2020 14:05:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
uterine fibroidsInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-21-2020 14:05:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-21-2020 14:05:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943433
Page 110 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f
Date Location User Value Reason
Oct-21-2020 14:06:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:myomectomy
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/
2004Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943434
Page 111 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:06:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:06:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
myomectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-21-2020 14:06:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-21-2020 14:06:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.g
Date Location User Value Reason
Oct-21-2020 14:06:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:cosmetic rhinop
lasty
Start Date: UNK/UNK/199
8Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943435
Page 112 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/
1998
1.g Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:06:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:06:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cosmetic rhinoplastyInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-21-2020 14:06:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-21-2020 14:06:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.h
Date Location User Value Reason
Oct-21-2020 14:07:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943436
Page 113 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical History
Term:incisional herni
a
Start Date: UNK/UNK/200
8
Ongoing: NO
End Date:
UNK/UNK/
2008
1.h Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:07:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:07:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
incisional herniaInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-21-2020 14:07:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-21-2020 14:07:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.i
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943437
Page 114 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical Histor
y Term:incisional hernia
repair
Start Date: UNK/UNK/200
8
Ongoing: NO
End Date:
UNK/UNK/2
008Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
incisional hernia repairInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-21-2020 14:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-21-2020 14:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943438
Page 115 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.j
Date Location User Value Reason
Oct-21-2020 14:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:femoral hernia
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943439
Page 116 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.j Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
femoral herniaInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-21-2020 14:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-21-2020 14:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943440
Page 117 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.k
Date Location User Value Reason
Oct-21-2020 14:09:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:femoral hernia r
epair
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943441
Page 118 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.k Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:09:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:09:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
femoral hernia repairInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-21-2020 14:09:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-21-2020 14:09:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.l
Date Location User Value Reason
Oct-21-2020 14:10:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:inguinal hernia
Start Date: UNK/UNK/20
17Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943442
Page 119 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/
2017
1.l Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:10:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:10:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inguinal herniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-21-2020 14:10:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-21-2020 14:10:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.m
Date Location User Value Reason
Oct-21-2020 14:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943443
Page 120 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical History
Term:inguinal hernia
repair
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017
1.m Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inguinal hernia repairInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-21-2020 14:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-21-2020 14:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.n
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943444
Page 121 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-21-2020 14:10:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical History
Term:thyroidectomy
Start Date: UNK/UNK/20
10
Ongoing: NO
End Date:
UNK/UNK/
2010Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943445
Page 122 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.n Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:10:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:10:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
thyroidectomyInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-21-2020 14:10:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Oct-21-2020 14:10:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.o
Date Location User Value Reason
Oct-21-2020 14:11:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:15
Medical Histo
ry Term:benign right breast
papilloma
Start Date: UNK/UNK/2018Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943446
Page 123 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/20
18
1.o Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:11:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:11:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
benign right breast papillomaInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-21-2020 14:11:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-21-2020 14:11:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.p
Date Location User Value Reason
Oct-21-2020 14:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943447
Page 124 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical Histor
y Term:right breast duct
excision
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018
1.p Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 14:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
right breast duct excisionInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-21-2020 14:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-21-2020 14:11:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.q
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943448
Page 125 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:13:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical Hi
story Term
:II/VI systolic ejectio
n heart murmur diag
nosed
Start Date: Oct/21/2020
Ongoing: YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943449
Page 126 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.q Line/MH Number:
Date Location User Value Reason
Oct-21-2020 14:13:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 08:57:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 07:11:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PI said this is NCS
and does not fit any
exclusion criterion.
Oct-28-2020 02:04:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: For this
very recent finding,
please provide the
investigator's
assessment towards
Inclusion #3 and
Exclusion #1.
Oct-27-2020 13:14:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery: For this
very recent finding,
please provide the
investigator's
assessment towards
Inclusion #3 and
Exclusion #1.
Oct-21-2020 14:13:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
II/VI systolic ejection heart mur
mur diagnosedInitial Entry
1.q Start Date:
Date Location User Value Reason
Oct-22-2020 05:38:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943450
Page 127 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:17:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Diagnosed by PI
during
pre-vaccination
study physical.
NCS. OK for
subject to enroll in
study, per PI.
Oct-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
21/Oct/2020. Please
review and update
as appropriate.
Oct-21-2020 14:13:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
1.q Ongoing:
Date Location User Value Reason
Oct-21-2020 14:13:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943451
Page 128 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020 14:12:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943452
Page 129 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
178.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
62.25Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.3Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943453
Page 130 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020 14:12:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943454
Page 131 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943455
Page 132 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020 14:14:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943456
Page 133 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020 14:15:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020 14:15:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
111199Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943457
Page 134 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 14:15:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 14:15:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 18:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 14:15:17
(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-21-2020 14:15:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 18:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJGJNInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943458
Page 135 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 18:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJGJNInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020 18:19:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJGJPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 18:19:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJGJPInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 18:19:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6JX5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 18:19:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6JX5Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943459
Page 136 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 14:15:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 14:15:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 18:19:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 14:15:25
(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-21-2020 14:15:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 18:19:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR921WInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943460
Page 137 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 18:19:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR921WInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943461
Page 138 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 14:15:41
(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-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 12:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 14:15:41
(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-21-2020 14:15:41
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)
(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943462
Page 139 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-21-2020 14:15:41
(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-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-21-2020 14:15:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943463
Page 140 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-21-2020 14:16:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943464
Page 141 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 11:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943465
Page 142 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2.a
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943466
Page 143 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Nov-11-2020 11:46:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943467
Page 144 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-11-2020 11:47:00
(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-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-11-2020 11:47:00
(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-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943468
Page 145 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-11-2020 11:47:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943469
Page 146 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 11:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 11:47:16
(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-13-2020 06:52:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed barcode entered
Nov-11-2020 17:41:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This is TODAY!
Why are you
querying before I
even have a chance
to enter this so I
have to answer a
query first?
Nov-11-2020 17:30:07
(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.
Nov-11-2020 11:47:16
(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.
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943470
Page 147 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-11-2020 11:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 17:41:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9259Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 17:41:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9259Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943471
Page 148 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-11-2020 11:47:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-11-2020 11:47:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-11-2020 11:47:36
(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-11-2020 11:47:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020 10:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020 11:47:36
(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-11-2020 11:47:36
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943472
Page 149 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-11-2020 11:47:36
(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-11-2020 11:47:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-11-2020 11:47:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943473
Page 150 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-09-2020 10:19:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943474
Page 151 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 10:19:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 10:19:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020 15:48:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 10:19:33
(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-09-2020 10:19:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020 15:48:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJNCYInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943475
Page 152 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Dec-09-2020 15:48:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJNCYInitial Entry
5.b
Date Location User Value Reason
Dec-09-2020 15:48:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJNCZInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-09-2020 15:48:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJNCZInitial Entry
5.c
Date Location User Value Reason
Dec-09-2020 15:48:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6K8KInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-09-2020 15:48:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6K8KInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943476
Page 153 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943477
Page 154 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943478
Page 155 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943479
Page 156 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943480
Page 157 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943481
Page 158 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-18-2020 16:20:41
(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
Nov-18-2020 17:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Fever (101.9 F)Changed
Information
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/24/2020 UNK:UNKInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943482
Page 159 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6. Toxicity Grade:
Date Location User Value Reason
Nov-18-2020 17:55:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Changed
Information
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-18-2020 16:20:41
(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
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-18-2020 16:20:41 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943483
Page 160 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-18-2020 16:20:41
(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
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-18-2020 16:20:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943484
Page 161 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/22/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943485
Page 162 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-18-2020 16:22:22
(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
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943486
Page 163 of 203
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-18-2020 16:22:22
(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
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-18-2020 16:22:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943487
Page 164 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 17:29:04
(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-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Ear PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 06:27:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 17:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered attempted to
contact subject,
will keep trying
Mar-03-2021 14:18:35 ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943488
Page 165 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US & Canada)verify if Left Ear
Pain is ongoing,
then update the
END DATE and
OUTCOME as
appropriate
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 17:29:04
(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
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 17:29:04
(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-10-2021 17:29:04
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943489
Page 166 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Unknown - Possible Infec
tion (ENT Consult Pendin
g)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 17:29:04
(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-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 17:29:04
(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
Feb-10-2021 17:29:04
(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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943490
Page 167 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 17:29:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943491
Page 168 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 17:29:54
(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-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Swollen Lymph Nodes (Left Ja
w)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 06:27:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 17:29:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered attempted to
contact subject,
will keep trying
Mar-03-2021 14:19:11 ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943492
Page 169 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US & Canada)verify if Swollen
Lymph Node (Left
Jaw) is ongoing,
then update the
END DATE and
OUTCOME as
appropriate
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 17:29:54
(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
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 17:29:54
(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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943493
Page 170 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Unknown - Possible Infec
tion (ENT Consult Pendin
g)Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 17:29:54
(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-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 17:29:54
(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
Feb-10-2021 17:29:54
(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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943494
Page 171 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 17:29:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943495
Page 172 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 17:30:41
(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-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Swollen Lymph Nodes (Left Ne
ck)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 06:27:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 17:29:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered attempted to
contact subject,
will keep trying
Mar-03-2021 14:19:38 ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943496
Page 173 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US & Canada)verify if Swollen
Lymph Node (Left
Neck) is ongoing,
then update the
END DATE and
OUTCOME as
appropriate
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 17:30:41
(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
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 17:30:41
(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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943497
Page 174 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Unknown - Possible Infec
tion (ENT Consult Pendin
g)Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 17:30:41
(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-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 17:30:41
(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
Feb-10-2021 17:30:41
(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
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943498
Page 175 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 17:30:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943499
Page 176 of 203
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-09-2020 10:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-09-2020 10:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-09-2020 10:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943500
Page 177 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 10:34:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943501
Page 178 of 203
***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, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-18-2020 10:34:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943502
Page 179 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 10:34:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943503
Page 180 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-18-2020 10:34:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/18/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943504
Page 181 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-18-2020 10:35:16
(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 10:35:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 10:35:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943505
Page 182 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943506
Page 183 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-18-2020 10:35:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943507
Page 184 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 10:44:49
(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 10:44:49
(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 20:38:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 10:44:49
(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 10:44:49
(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 20:38:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRGVRDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943508
Page 185 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 20:38:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRGVRDInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 20:38:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRGVRFInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 20:38:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRGVRFInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 20:39:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6KCWTranscription Error
Dec-18-2020 20:38:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6KCWNInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (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-2021-5683-0943509
Page 186 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 20:39:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-18-2020 20:39:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6KCWTranscription Error
Dec-18-2020 20:38:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Dec-18-2020 20:38:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6KCWNInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0943510
Page 187 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 10:46:28
(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 10:46:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 20:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 10:46:28
(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 10:46:28
(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 20:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRRKXJInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943511
Page 188 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 20:39:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRRKXJInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943512
Page 189 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020 08:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943513
Page 190 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-18-2020 10:46:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943514
Page 191 of 203
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-18-2020 10:33:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-18-2020 10:33:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943515
Page 192 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 09:43:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943516
Page 193 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943517
Page 194 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-08-2021 09:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943518
Page 195 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 09:45:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 09:45:00
(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-08-2021 18:52:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 09:45:00
(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-08-2021 09:45:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021 18:52:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRRL3HInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943519
Page 196 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Jan-08-2021 18:52:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRRL3HInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943520
Page 197 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021 08:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943521
Page 198 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-08-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943522
Page 199 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 12:41:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-11-2021 08:22:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered DONE
Feb-11-2021 03:42:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Feb-10-2021 17:27:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943523
Page 200 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-10-2021 17:27:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-10-2021 17:27:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/10/2021Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943524
Page 201 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-12-2021
04:49:05
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedIncorrect Query
Feb-11-2021
13:37:28
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7235742;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-11-2021
08:22:34
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1
0/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-11-2021 08:22:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-11-2021 08:22:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943525
Page 202 of 203
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-09-2020 10:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-21-2020 14:15:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-21-2020 14:03:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-09-2020 10:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2020Initial Entry
Oct-21-2020 14:15:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Oct-21-2020 14:03:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943526
Page 203 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521551 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-09-2020 10:20:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fd7\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943527