125742 S1 M5 CRF c4591001 1066 10661202

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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Page 1 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788139
Page 2 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/7/2020
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788140
Page 3 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10661202]
2.Birth Date: /1978
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:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788141
Page 4 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788142
Page 5 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788143
Page 6 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788144
Page 7 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[endometriosis]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acne]
Start Date: UNK/UNK/1996
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788145
Page 8 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
2.Weight: [150.1]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [22.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788146
Page 9 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788147
Page 10 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/7/2020
2.Randomization Number: [83098]
3.Randomization Group: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788148
Page 11 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
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 [BP84RH]
5.bSample ID [BNWH14]
5.cSample ID [BNWH15]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788149
Page 12 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
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 [BP84R5]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788150
Page 13 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 12:34
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788151
Page 14 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788152
Page 15 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788153
Page 16 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788154
Page 17 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788155
Page 18 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BP85BZ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788156
Page 19 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/30/2020 16:58
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788157
Page 20 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788158
Page 21 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BR6TYL]
5.bSample ID [BS5F32]
5.cSample ID [BS5F33]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788159
Page 22 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788160
Page 23 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788161
Page 24 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788162
Page 25 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788163
Page 26 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788164
Page 27 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788165
Page 28 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788166
Page 29 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788167
Page 30 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788168
Page 31 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788169
Page 32 of 162
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788170
Page 33 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788171
Page 34 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788172
Page 35 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788173
Page 36 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  fever  Jan/8/2021 UN
K:UNK NO
End Date Time:
Jan/9/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE E
VENT 2  fatigue  Jan/8/2021 UN
K:UNK NO
End Date Time:
Jan/10/2021 UNK:UN
K
 Repeating
Pages
 3.ADVERSE E
VENT 3  L side axillary lymph no
de swelling Jan/8/2021 UN
K:UNK NO
End Date Time:
Jan/10/2021 UNK:UN
K
 Repeating
Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788174
Page 37 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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]
4.Start Date Time: Jan/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/9/2021 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?YES
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788175
Page 38 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788176
Page 39 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: Jan/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788177
Page 40 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788178
Page 41 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[L side axillary lymph node swelling]
4.Start Date Time: Jan/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788179
Page 42 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788180
Page 43 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788181
Page 44 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788182
Page 45 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788183
Page 46 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788184
Page 47 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788185
Page 48 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788186
Page 49 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788187
Page 50 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788188
Page 51 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788189
Page 52 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788190
Page 53 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788191
Page 54 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788192
Page 55 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788193
Page 56 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788194
Page 57 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788195
Page 58 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788196
Page 59 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788197
Page 60 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788198
Page 61 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788199
Page 62 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/17/2020
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788200
Page 63 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788201
Page 64 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/17/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788202
Page 65 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788203
Page 66 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BS3C2X]
5.bSample ID [BS3C2Y]
5.cSample ID [BRDL65]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788204
Page 67 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BRDL5V]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788205
Page 68 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/17/2020 07:35
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788206
Page 69 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788207
Page 70 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788208
Page 71 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788209
Page 72 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788210
Page 73 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
Not Done: NOT DONE
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788211
Page 74 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [BRDLBL]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788212
Page 75 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 07:34
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788213
Page 76 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788214
Page 77 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/11/2021
3.Comments: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788215
Page 78 of 162
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788216
Page 79 of 162
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788217
Page 80 of 162
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788218
Page 81 of 162
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788219
Page 82 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788220
Page 83 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788221
Page 84 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788222
Page 85 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788223
Page 86 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-07-2020 13:58:40 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788224
Page 87 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-17-2020 08:22:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788225
Page 88 of 162
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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-11-2021 12:23:21 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Butuk  Approved Jan-25-2021 21:17:07 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidButuk, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-17-2020 08:20:58 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Butuk  Approved Nov-02-2020 13:58:39 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidButuk, 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.
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788226
Page 89 of 162
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
 N/A Oct-30-2020 15:56:28 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Butuk  Approved Oct-22-2020 07:57:00 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidButuk, 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.
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788227
Page 90 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-07-2020 13:58:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-07-2020 13:58:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788228
Page 91 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-07-2020 13:58:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/7/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788229
Page 92 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-07-2020 13:57:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10661202Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020 13:57:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1978Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-07-2020 13:58:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-07-2020 13:58:22
(UTC-07:00) Mountain
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
Sep-07-2020 13:58:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788230
Page 93 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 13:58:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788231
Page 94 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-07-2020 13:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-07-2020 13:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-07-2020 13:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788232
Page 95 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020 13:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:depression
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-07-2020 13:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 13:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-07-2020 13:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-07-2020 13:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788233
Page 96 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Sep-07-2020 13:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:endometriosis
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2019Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788234
Page 97 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Sep-07-2020 13:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 13:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
endometriosisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-07-2020 13:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-07-2020 13:59:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Sep-07-2020 13:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:acne
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788235
Page 98 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Sep-07-2020 13:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 13:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
acneInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-07-2020 13:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-07-2020 13:59:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-07-2020 14:00:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:hysterectomy
Start Date: UNK/UNK/201
9Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788236
Page 99 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK/
2019
1.d Line/MH Number:
Date Location User Value Reason
Sep-07-2020 14:00:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 14:00:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hysterectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-07-2020 14:00:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-07-2020 14:00:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788237
Page 100 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
150.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) MountainACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.2Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788238
Page 101 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.2
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 14:00:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788239
Page 102 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788240
Page 103 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-07-2020 14:00:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788241
Page 104 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-07-2020 14:00:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020 14:00:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
83098Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788242
Page 105 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 14:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 14:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 15:09:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 14:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 14:01:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 15:09:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP84RHInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788243
Page 106 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 15:09:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP84RHInitial Entry
5.b
Date Location User Value Reason
Sep-07-2020 15:09:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWH14Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-07-2020 15:09:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWH14Initial Entry
5.c
Date Location User Value Reason
Sep-07-2020 15:09:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWH15Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020 15:09:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWH15Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788244
Page 107 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 14:01:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 14:01:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 15:08:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 14:01:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 14:01:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 15:08:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP84R5Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788245
Page 108 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 15:08:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP84R5Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788246
Page 109 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/7/2020 12:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788247
Page 110 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
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
Sep-07-2020 14:01:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788248
Page 111 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020 14:01:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788249
Page 112 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 16:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788250
Page 113 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788251
Page 114 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 16:51:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788252
Page 115 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788253
Page 116 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-30-2020 16:51:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788254
Page 117 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 16:47:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 16:47:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 16:47:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 16:47:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 16:47:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 16:47:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP85BZInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788255
Page 118 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 16:47:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP85BZInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788256
Page 119 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 16:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788257
Page 120 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 07:05:06
(UTC-07:00) Mountain
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-01-2020 07:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788258
Page 121 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 15:56:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788259
Page 122 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 15:56:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 15:56:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 16:00:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 15:56:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 15:56:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 16:00:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR6TYLInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788260
Page 123 of 162
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 16:00:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR6TYLInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 16:01:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS5F32Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 16:01:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS5F32Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 16:01:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS5F33Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 16:01:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS5F33Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788261
Page 124 of 162
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-02-2020 12:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 12:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 12:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788262
Page 125 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788263
Page 126 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788264
Page 127 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788265
Page 128 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
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
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
feverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/9/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788266
Page 129 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
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
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
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
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788267
Page 130 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
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
Jan-11-2021 13:49:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788268
Page 131 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
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
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
fatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788269
Page 132 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
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
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
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
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788270
Page 133 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 13:51:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
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
Jan-11-2021 13:50:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788271
Page 134 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
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
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
L side axillary lymph node swell
ingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788272
Page 135 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
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
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
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
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (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-2021-5683-0788273
Page 136 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
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
Jan-11-2021 13:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788274
Page 137 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 08:20:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788275
Page 138 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-17-2020 08:25:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 08:21:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-17-2020 08:21:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788276
Page 139 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 08:21:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788277
Page 140 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-17-2020 08:21:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/17/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788278
Page 141 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-17-2020 08:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020 08:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020 08:22:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788279
Page 142 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788280
Page 143 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Dec-17-2020 08:23:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788281
Page 144 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 08:24:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 08:24:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 09:42:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 08:24:00
(UTC-07:00) Mountain
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-17-2020 08:24:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 09:42:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3C2XInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788282
Page 145 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 09:42:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS3C2XInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020 09:42:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3C2YInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 09:42:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS3C2YInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 09:43:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDL65Transcription Error
Dec-17-2020 09:42:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDL5VInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 09:43:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRDL65Transcription Error
Dec-17-2020 09:42:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRDL5VInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788283
Page 146 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 08:24:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 08:24:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 09:42:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 08:24:11
(UTC-07:00) Mountain
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-17-2020 08:24:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 09:42:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDL5VInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788284
Page 147 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 09:42:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRDL5VInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788285
Page 148 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020 07:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788286
Page 149 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-17-2020 08:24:36
(UTC-07:00) Mountain
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-17-2020 08:24:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788287
Page 150 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020 08:25:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020 08:25:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788288
Page 151 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 08:07:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788289
Page 152 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788290
Page 153 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-08-2021 08:08:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788291
Page 154 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 08:08:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 08:08:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021 08:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 08:08:14
(UTC-07:00) Mountain
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 08:08:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021 08:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDLBLInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788292
Page 155 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Jan-08-2021 08:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRDLBLInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788293
Page 156 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 07:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788294
Page 157 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 08:08:34
(UTC-07:00) Mountain
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 08:08:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788295
Page 158 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 12:23:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2021Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788296
Page 159 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-11-2021 12:23:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-11-2021 12:23:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Feb/11/2021Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0788297
Page 160 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-12-2021
03:54:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedIncorrect Query
Feb-11-2021
20:59:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7238456;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
12:23:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/1
1/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-11-2021 12:23:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-11-2021 12:23:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788298
Page 161 of 162
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-02-2020 12:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-07-2020 14:00:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-07-2020 13:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-02-2020 12:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Sep-07-2020 14:00:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/7/2020Initial Entry
Sep-07-2020 13:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/7/2020Initial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788299
Page 162 of 162
***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, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661202 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 10:17:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae30ed\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788300