Document text
Page 1 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835121
Page 2 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/12/2020
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835122
Page 3 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12541142]
2.Birth Date: 1998
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835123
Page 4 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/12/2020
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835124
Page 5 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835125
Page 6 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835126
Page 7 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Miscarriage]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2019
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benedryl Allergy]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835127
Page 8 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/12/2020
2.Weight: [63.05]
3.Unit: kg
4.Height: [162.6]
5.Unit: cm
6.Body Mass Index: [23.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: EAR
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835128
Page 9 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835129
Page 10 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/12/2020
2.Randomization Number: [89228]
3.Randomization Group: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835130
Page 11 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8K1F]
5.bSample ID [BLG868]
5.cSample ID [BLG869]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835131
Page 12 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8K1D]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835132
Page 13 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/12/2020 13:13
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
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835133
Page 14 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835134
Page 15 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020 Comments
2.Erroneous Visit Comments
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835135
Page 16 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Nov/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: EAR
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835136
Page 17 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835137
Page 18 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [BN9TZN]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835138
Page 19 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835139
Page 20 of 226
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835140
Page 21 of 226
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS67YZ]
5.bSample ID [BS67Z0]
5.cSample ID [BN9V1S]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835141
Page 22 of 226
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835142
Page 23 of 226
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835143
Page 24 of 226
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835144
Page 25 of 226
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835145
Page 26 of 226
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835146
Page 27 of 226
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835147
Page 28 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835148
Page 29 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835149
Page 30 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835150
Page 31 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835151
Page 32 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835152
Page 33 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835153
Page 34 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835154
Page 35 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835155
Page 36 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835156
Page 37 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835157
Page 38 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835158
Page 39 of 226
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835159
Page 40 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835160
Page 41 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835161
Page 42 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 left eye redness Sep/12/2020 16:00
NO
End Date Time:
Sep/14/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 left eye irritation Sep/12/2020 16:00
NO
End Date Time:
Sep/14/2020 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 intermittent chills Sep/12/2020 22:00
NO
End Date Time:
Sep/25/2020 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 elevated body temperature
at 100.0F Sep/13/2020 07:30
NO
End Date Time:
Sep/14/2020 04:00
Repeating
Pages
5.ADVERSE E
VENT 5 fever at 102.0F Sep/14/2020 04:00
NO
End Date Time:
Sep/14/2020 08:00
Repeating
Pages
6.ADVERSE E
VENT 6 elevated body temperature
at 100.0F Sep/14/2020 10:00
NO
End Date Time:
Sep/15/2020 UNK:UN
K
Repeating
Pages
7.ADVERSE E
VENT 7 stomach pain Sep/15/2020 09:00
NO
End Date Time:
Sep/15/2020 14:00
Repeating
Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835162
Page 43 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
8.ADVERSE E
VENT 8 headache intermittent Sep/15/2020 UNK:
UNK NO
End Date Time:
Sep/25/2020 UNK:UN
K
Repeating
Pages
9.ADVERSE E
VENT 9 Nausea Sep/26/2020 UNK:
UNK YES Repeating
Pages
10.ADVERSE E
VENT 10 Maternal Exposure Durin
g Pregnancy Sep/12/2020 13:13
YES Repeating
Pages
11.ADVERSE E
VENT 11 hair loss Oct/UNK/2020 U
NK:UNK YES Repeating
Pages
12.ADVERSE E
VENT 12 weight loss Oct/UNK/2020 U
NK:UNK YES Repeating
Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835163
Page 44 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[left eye redness]
4.Start Date Time: Sep/12/2020 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835164
Page 45 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835165
Page 46 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[left eye irritation]
4.Start Date Time: Sep/12/2020 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835166
Page 47 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835167
Page 48 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[intermittent chills]
4.Start Date Time: Sep/12/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/25/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835168
Page 49 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835169
Page 50 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[elevated body temperature at 100.0F]
4.Start Date Time: Sep/13/2020 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 04:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835170
Page 51 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835171
Page 52 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fever at 102.0F]
4.Start Date Time: Sep/14/2020 04:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 08:00
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
12.Was a Non-Drug Treatment given? NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835172
Page 53 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835173
Page 54 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[elevated body temperature at 100.0F]
4.Start Date Time: Sep/14/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835174
Page 55 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835175
Page 56 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[stomach pain]
4.Start Date Time: Sep/15/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 14:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology but due to gas]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835176
Page 57 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835177
Page 58 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache intermittent]
4.Start Date Time: Sep/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835178
Page 59 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835179
Page 60 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Likely From Pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835180
Page 61 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835181
Page 62 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Maternal Exposure During Pregnancy]
4.Start Date Time: Sep/12/2020 13:13
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835182
Page 63 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835183
Page 64 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[hair loss]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835184
Page 65 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835185
Page 66 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [12]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[weight loss]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835186
Page 67 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835187
Page 68 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835188
Page 69 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835189
Page 70 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835190
Page 71 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: //
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835191
Page 72 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835192
Page 73 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835193
Page 74 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835194
Page 75 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835195
Page 76 of 226
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835196
Page 77 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835197
Page 78 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835198
Page 79 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835199
Page 80 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835200
Page 81 of 226
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835201
Page 82 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835202
Page 83 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835203
Page 84 of 226
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835204
Page 85 of 226
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835205
Page 86 of 226
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835206
Page 87 of 226
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835207
Page 88 of 226
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835208
Page 89 of 226
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835209
Page 90 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Done
//Comments
2.Primary Reason for Unblinding: Not Done Comments
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835210
Page 91 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Done
//Comments
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835211
Page 92 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835212
Page 93 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/7/2020
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835213
Page 94 of 226
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835214
Page 95 of 226
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Heller Approved Jan-21-2021 19:35:04 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835215
Page 96 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-12-2020 16:33:37 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835216
Page 97 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-14-2020 11:18:46 (UTC-08:00) Pacific
Time (US & Canada)
FormOct-30-2020 09:10:02 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835217
Page 98 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-14-2020 11:18:46 (UTC-08:00) Pacific Time
(US & Canada)
1Oct-30-2020 09:10:02 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835218
Page 99 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-14-2020 11:18:46 (UTC-08:00) Pacific Time
(US & Canada)
2Oct-30-2020 09:10:02 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835219
Page 100 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 17:40:00 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835220
Page 101 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835221
Page 102 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835222
Page 103 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835223
Page 104 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835224
Page 105 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835225
Page 106 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835226
Page 107 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835227
Page 108 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835228
Page 109 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835229
Page 110 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835230
Page 111 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Nov-13-2020 17:40:00 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835231
Page 112 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-16-2020 13:27:33 (UTC-08:00) Pacific Time
(US & Canada)Per DM, toxicity grade for this AE should be NA.
Data updated.
Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835232
Page 113 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-28-2020 15:13:14 (UTC-08:00) Pacific Time
(US & Canada)unblinding was not done
Not Done
FormOct-26-2020 16:39:35 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835233
Page 114 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-28-2020 15:13:14 (UTC-08:00) Pacific Time
(US & Canada)unblinding was not done
Not Done
1Oct-26-2020 16:39:35 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835234
Page 115 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-28-2020 15:13:14 (UTC-08:00) Pacific Time
(US & Canada)unblinding was not done
Not Done
2Oct-26-2020 16:39:35 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835235
Page 116 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-28-2020 15:13:57 (UTC-08:00) Pacific Time
(US & Canada)Subject DID NOT withdrew consent
Not Done
FormOct-26-2020 16:39:50 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835236
Page 117 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-28-2020 15:13:57 (UTC-08:00) Pacific Time
(US & Canada)Subject DID NOT withdrew consent
Not Done
1Oct-26-2020 16:39:50 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835237
Page 118 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-26-2020 16:40:03 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835238
Page 119 of 226
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-26-2020 16:40:03 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835239
Page 120 of 226
***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, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Heller Approved Jan-21-2021 19:35:04 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-25-2020 10:09:52 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller Approved Nov-17-2020 14:26:28 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 13:27:01 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller Approved Nov-14-2020 19:21:35 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835240
Page 121 of 226
***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, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 14:56:26 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller Approved Nov-03-2020 18:27:22 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-03-2020 10:35:42 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller Approved Oct-30-2020 18:19:41 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835241
Page 122 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-12-2020 16:32:58
(UTC-08:00) Pacific 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-12-2020 16:32:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835242
Page 123 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-12-2020 16:33:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/12/2020Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835243
Page 124 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-12-2020 16:32:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12541142Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-12-2020 16:32:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1998Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-12-2020 16:33:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-12-2020 16:33:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-12-2020 16:33:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835244
Page 125 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-12-2020 16:33:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835245
Page 126 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-12-2020 16:33:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-12-2020 16:33:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-12-2020 16:33:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835246
Page 127 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-12-2020 16:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-12-2020 16:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020 16:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-12-2020 16:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-12-2020 16:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835247
Page 128 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-12-2020 16:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Anxiety
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-12-2020 16:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020 16:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-12-2020 16:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-12-2020 16:34:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-12-2020 16:36:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835248
Page 129 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical History
Term:Recurrent Miscar
riage
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2
019
1.c Line/MH Number:
Date Location User Value Reason
Sep-12-2020 16:36:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020 16:36:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent MiscarriageInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-12-2020 16:36:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-12-2020 16:36:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.d
Date Location User Value Reason
Sep-12-2020 16:37:02
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835249
Page 130 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada) Medical History Te
rm:Benedryl Alle
rgy
Start Date: UNK/UNK/20
19
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-12-2020 16:37:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020 16:37:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Benedryl AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-12-2020 16:37:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-12-2020 16:37:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835250
Page 131 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
63.05Initial Entry
3. Unit:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
162.6Initial Entry
5. Unit:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.8Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835251
Page 132 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-12-2020 16:37:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835252
Page 133 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-14-2020 12:51:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-12-2020 16:39:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of collection is
reported, but result
is missing. Please
review and update as
appropriate.
Sep-12-2020 16:39:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835253
Page 134 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-14-2020 12:51:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defin
ed Identifier:
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-14-2020 12:51:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-12-2020 16:39:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-14-2020 12:51:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835254
Page 135 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-12-2020 16:43:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-12-2020 16:43:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
89228Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835255
Page 136 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 16:06:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 16:06:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 16:06:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 16:06:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 16:06:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/12/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 16:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8K1FInitial Entry
5.a Sample ID
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835256
Page 137 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-14-2020 16:06:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8K1FInitial Entry
5.b
Date Location User Value Reason
Sep-14-2020 16:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG868Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 16:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLG868Initial Entry
5.c
Date Location User Value Reason
Sep-14-2020 16:23:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG869Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-14-2020 16:23:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLG869Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835257
Page 138 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 16:41:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 16:41:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 16:41:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 16:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 16:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/12/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 16:41:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8K1DInitial Entry
5.a Sample ID
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835258
Page 139 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-14-2020 16:41:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8K1DInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835259
Page 140 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 13:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835260
Page 141 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-12-2020 16:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835261
Page 142 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-12-2020 16:44:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835262
Page 143 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-25-2020
10:39:19 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-25-2020
10:09:52 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Nov-16-2020
14:43:46 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Nov-16-2020
13:07:22 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered Yes, subject is out of
window and this is a
protocol deviation. Subject
was not able to come back
as she was dealing with the
pregnancy news in early
October and had a lot of
think about before resuming
the study.
Nov-16-2020
07:16:42 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: Date of visit at
V2_VAX2_L is out of
window for 39 days from
V1_DAY1_VAX1_L Dose
Date. Please verify and
update. Else, confirm in
query response
appropriately.
Nov-14-2020 11:18:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
Nov-14-2020 11:18:46
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835263
Page 144 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
Oct-30-2020 13:11:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-30-2020 09:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered completed
Oct-30-2020 09:10:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-30-2020 05:30:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Opened Please enter a FORM Level
comment of NOT DONE.
2. Erroneous Visit
Date Location User Value Reason
Nov-14-2020 11:18:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-30-2020 09:10:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835264
Page 145 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2.a
Date Location User Value Reason
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835265
Page 146 of 226
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-13-2020 17:38:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835266
Page 147 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835267
Page 148 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada) d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: POSITIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-13-2020 17:39:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-16-2020 14:43:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-16-2020 13:06:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject's urine
pregnancy is
positive, data
entered as correct.
Please note that
Exposure during
pregnancy has been
reported.
Nov-14-2020 20:53:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: Result is
POSITIVE however,
Subject is
Randomized. Please
review and correct
or confirm."
Nov-14-2020 08:05:20
(UTC-08:00) PacificACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835268
Page 149 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
Nov-13-2020 17:39:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This pregnancy has
been reported to
EDP on
07-OCT-2020
Nov-13-2020 17:39:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Lab result is
“Positive”, but
subject has been
vaccinated. Please
review and update
as appropriate. Else
explain.
Nov-13-2020 17:39:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835269
Page 150 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 16:51:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:50:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 16:50:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 16:51:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN9TZNInitial Entry
5.a Sample ID
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835270
Page 151 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-13-2020 16:51:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN9TZNInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835271
Page 152 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835272
Page 153 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-13-2020 17:40:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835273
Page 154 of 226
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 17:20:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835274
Page 155 of 226
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 17:20:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 17:20:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 17:20:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 17:20:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 17:20:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 17:20:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS67YZInitial Entry
5.a Sample ID
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835275
Page 156 of 226
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Dec-18-2020 17:20:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS67YZInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 17:21:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS67Z0Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 17:21:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS67Z0Initial Entry
5.c
Date Location User Value Reason
Dec-18-2020 17:21:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN9V1SInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 17:21:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN9V1SInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835276
Page 157 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 11:29:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-15-2020 10:33:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-15-2020 10:33:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
Oct-13-2020 06:51:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: AE
reported with action
taken of DRUG
WITHDRAWN.
Please complete the
end of treatment
disposition form
accordingly if
appropriate, else
clarify.
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 10:33:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User ValueReason
Oct-25-2020
11:53:22
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-21-2020 ACV0PFEINFP6000 QueryPositive pregnancy was
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835277
Page 158 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
21:26:37
(UTC-08:00)
Pacific Time
(US &
Canada)1: Ans
weredfound in subject's
medical record as subject
stated that she went to
her PCP and was tested
positive there.
Oct-16-2020
03:51:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW5003190;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Oct-15-2020
10:33:24
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
PREG
NAN
CYInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835278
Page 159 of 226
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-25-2020 10:39:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Nov-25-2020 10:09:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
Oct-27-2020 11:57:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-27-2020 11:51:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered page blanked out
Oct-27-2020 06:10:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY:
Please also remove
the data entered in
the STATUS field on
this CRF page if
appropriate. Thank
you.
Oct-26-2020 16:51:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-26-2020 16:51:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-26-2020 10:38:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: The
disposition follow up
CRF should be
completed for
subjects who did not
complete the
treatment period
AND do not agree to
remain in the study
for follow-up. Please
confirm the subject
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835279
Page 160 of 226
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
did not agree to
remain in the study,
else clarify.
Oct-23-2020 16:15:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-25-2020 10:39:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Nov-25-2020 10:09:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-26-2020 16:51:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-23-2020 16:15:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User ValueReason
Nov-25-2020
10:40:06
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Transcription Error
Nov-25-2020
10:09:52
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
PREG
NAN
CYInitial Entry
Oct-27-2020
11:51:16
(UTC-08:00)
Pacific TimeACV0PFEINFP6000 Data
Entry
:Transcription Error
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835280
Page 161 of 226
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US &
Canada)
Oct-27-2020
00:42:32
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_08_AN
Oct-26-2020
00:15:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5172806;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Oct-23-2020
16:15:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
PREG
NAN
CYInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835281
Page 162 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835282
Page 163 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835283
Page 164 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835284
Page 165 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835285
Page 166 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835286
Page 167 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835287
Page 168 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835288
Page 169 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835289
Page 170 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835290
Page 171 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-12-2020 17:16:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835291
Page 172 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-13-2020 14:56:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835292
Page 173 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-13-2020 14:59:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835293
Page 174 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left eye rednessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/14/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-26-2020 12:21:24
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835294
Page 175 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
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
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-26-2020 12:21:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown etiologyNew Information
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835295
Page 176 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835296
Page 177 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left eye irritationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/14/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835297
Page 178 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-26-2020 12:23:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown etiologyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835298
Page 179 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-26-2020 13:10:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:12:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835299
Page 180 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
intermittent chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-26-2020 13:08:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/25/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835300
Page 181 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835301
Page 182 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-26-2020 13:08:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 13:08:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Sep-26-2020 13:08:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE intermittent
chills: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:13:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835302
Page 183 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperature at 100.
0FInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020 07:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/14/2020 04:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835303
Page 184 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-26-2020 12:25:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835304
Page 185 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835305
Page 186 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
fever at 102.0FInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 04:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/14/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835306
Page 187 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835307
Page 188 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:21:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835308
Page 189 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-26-2020 12:28:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperature at 100.
0FNew Information
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperatureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020 13:11:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-30-2020 13:02:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Estimated around
10:00AM
Sep-30-2020 13:02:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 10:00Estimated around
10:00AM
Sep-27-2020 13:57:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY: Is
start time for this AE
known? If not known
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835309
Page 190 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
is it possible to
estimate the time
based on source (see
CRF CR 4.6)? If yes,
please update the
start time in the CRF.
Sep-26-2020 12:29:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered query updated
Sep-25-2020 09:55:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please specify start
time as subject has
another similar AE
(fever at 102.0F)
reported as being
resolved same day
14/Sep/20 at 08:00.
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/15/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835310
Page 191 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835311
Page 192 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835312
Page 193 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
stomach painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/15/2020 14:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835313
Page 194 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-26-2020 12:30:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown etiology but due t
o gasNew Information
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835314
Page 195 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020 15:30:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835315
Page 196 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-27-2020 13:58:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-26-2020 13:06:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per investigator, this
is related to the
vaccine as it started
within 7 days from
the vaccination.
Sep-25-2020 09:59:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please confirm if
headache
intermittent could be
a COVID infection
related symptom.
Please consider
conducting a COVID
related illness visit
and swab collection
as soon as possible.
Thank you.
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
headache intermittentInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835316
Page 197 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-26-2020 13:07:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/25/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835317
Page 198 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-26-2020 12:32:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDNew Information
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-26-2020 13:05:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835318
Page 199 of 226
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020 15:35:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835319
Page 200 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-08-2020 12:06:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-08-2020 11:55:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered NOT RELATED TO
COVID
Oct-08-2020 09:19:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please confirm if
nausea could be a
COVID infection
related symptom.
Please consider
conducting a COVID
related illness visit
and swab collection
as soon as possible.
Oct-07-2020 11:47:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835320
Page 201 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-25-2020 21:33:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-25-2020 10:13:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Subject is continuing
for the follow up
visits.
Nov-25-2020 10:09:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-26-2020 16:51:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-23-2020 16:15:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-12-2020 19:14:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-12-2020 17:14:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered It is still ongoing.
Oct-08-2020 10:51:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please review if this
event remains
ongoing or if an
update to this field
and outcome status
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0835321
Page 202 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
can be entered.
Oct-07-2020 11:47:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 17:13:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:New Information
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835322
Page 203 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Likely From Pregnancy
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Uknown, pending medical rec
ordInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0835323
Page 204 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-07-2020 11:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e7c\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835324
Page 205 of 226
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541142 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 17:16:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 17:16:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 13:24:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Maternal Exposure During Pregnan
cyPreferred Term per
Pfizer Safety
Oct-12-2020 17:16:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 04:33:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 4: Clos
…[truncated]