Document text
Page 1 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907992
Page 2 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907993
Page 3 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10421166]
2.Birth Date: /1951
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907994
Page 4 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907995
Page 5 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907996
Page 6 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907997
Page 7 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN PROSTATIC HYPERPLASIA]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TORN ROTATOR CUFF RIGHT SIDE]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907998
Page 8 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TORN MENISCUS LEFT SIDE]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TORN ROTATOR CUFF LEFT SIDE]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ARTHROSCOPIC REPAIR LEFT SIDE]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROTATOR CUFF REPAIR RIGHT SIDE]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907999
Page 9 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROTATOR CUFF REPAIR LEFT SIDE]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908000
Page 10 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [160.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [25.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908001
Page 11 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [242502]
3.Randomization Group: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908002
Page 12 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[not enough serum for vile 5]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3MGZ]
5.bSample ID [BP3MH0]
5.cSample ID [BP3MH1]
5.dSample ID [BPLCY8]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908003
Page 13 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BN5R8W]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908004
Page 14 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 18:17
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
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908005
Page 15 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908006
Page 16 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908007
Page 17 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908008
Page 18 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BN5PYH]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908009
Page 19 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/14/2020
Reason(s) for Temporary Delay of Vaccination
ANTICIPATED NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/2/2020 09:56
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
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908010
Page 20 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908011
Page 21 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKZF1R]
5.bSample ID [BKZF1S]
5.cSample ID [BRD7TD]
5.dSample ID [BRD7TF]
5.eSample ID [BRD7TG]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908012
Page 22 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908013
Page 23 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908014
Page 24 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908015
Page 25 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908016
Page 26 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908017
Page 27 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908018
Page 28 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908019
Page 29 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908020
Page 30 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908021
Page 31 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908022
Page 32 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908023
Page 33 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908024
Page 34 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908025
Page 35 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908026
Page 36 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908027
Page 37 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908028
Page 38 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908029
Page 39 of 202
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908030
Page 40 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908031
Page 41 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908032
Page 42 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
1.ADVERSE
EVENT 1 SUBARACHNOID HEMORR
AGE Sep/3/2020 U
NK:UNK NO
End Date Time:
Sep/8/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE
EVENT 2 FALL Sep/3/2020 U
NK:UNK NO
End Date Time:
Sep/3/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE
EVENT 3 Left frontal lobe contusion Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:U
NK
Repeating
Pages
4.ADVERSE
EVENT 4 Acute Pain hip right side Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:U
NK
Repeating
Pages
5.ADVERSE
EVENT 5 Decreased Mobility Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/20/2020 UNK:U
NK
Repeating
Pages
6.ADVERSE
EVENT 6 Closed Fracture of Rt Interior
Pubic Ramus Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:U
NK
Repeating
Pages
7.ADVERSE
EVENT 7 Closed Fracture of Four Ribs Sep/3/2020 U
NK:UNK NO
End Date Time:Repeating
Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908033
Page 43 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
Oct/2/2020 UNK:U
NK
8.ADVERSE
EVENT 8 Closed Displaced Fracture of b
ody Right Scapula Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/20/2020 UNK:U
NK
Repeating
Pages
9.ADVERSE
EVENT 9 Muscle Spasm Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:U
NK
Repeating
Pages
10.ADVERSE
EVENT 10 Right Shoulder Pain Sep/3/2020 U
NK:UNK NO
End Date Time:
Oct/20/2020 UNK:U
NK
Repeating
Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908034
Page 44 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[SUBARACHNOID HEMORRAGE]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908035
Page 45 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[FALL]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020375982]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908036
Page 46 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[FALL]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 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:
[fall from bicycle]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908037
Page 47 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908038
Page 48 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left frontal lobe contusion]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 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:
[fall from bicycle]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908039
Page 49 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908040
Page 50 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Pain hip right side]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 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:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908041
Page 51 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908042
Page 52 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Decreased Mobility]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/20/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908043
Page 53 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908044
Page 54 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Closed Fracture of Rt Interior Pubic Ramus]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908045
Page 55 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908046
Page 56 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Closed Fracture of Four Ribs]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908047
Page 57 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908048
Page 58 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Closed Displaced Fracture of body Right Scapula]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/20/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908049
Page 59 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908050
Page 60 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle Spasm]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908051
Page 61 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908052
Page 62 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right Shoulder Pain]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/20/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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:
[Bicycle Fall]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908053
Page 63 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908054
Page 64 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908055
Page 65 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908056
Page 66 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.1 VACCINATIONS NO Tetanus shot Sep/3/20
20 Repeating
Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908057
Page 67 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Tetanus shot]
5.Date: Sep/3/2020
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908058
Page 68 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908059
Page 69 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908060
Page 70 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908061
Page 71 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908062
Page 72 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908063
Page 73 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908064
Page 74 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908065
Page 75 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908066
Page 76 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908067
Page 77 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908068
Page 78 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908069
Page 79 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908070
Page 80 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908071
Page 81 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908072
Page 82 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908073
Page 83 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908074
Page 84 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908075
Page 85 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908076
Page 86 of 202
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908077
Page 87 of 202
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908078
Page 88 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908079
Page 89 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908080
Page 90 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 16:56:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908081
Page 91 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-28-2020 07:46:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908082
Page 92 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-30-2020 12:17:22 (UTC-06:00) Central
Time (US & Canada)First two samples are Retain Samples (D) and
(E) respectively. Last three are Send Samples
(A) (B) (C) respectively.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908083
Page 93 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 16:56:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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 Feb-22-2021 09:53:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 12:14:48 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-11-2020 08:58:06 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908084
Page 94 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Nov-02-2020 15:40:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908085
Page 95 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 07:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 07:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908086
Page 96 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 07:44:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/26/2020Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908087
Page 97 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 07:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10421166Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 00:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-31-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-31-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1951Transcription Error
Aug-31-2020 00:47:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS
Reconciliation:
Subject age
calculated '54' based
on DOB and
randomization date
observed outside the
acceptable age
group (56 to 85)
specified per
(Strata) IVRS.
Please check and
update data as
appropriate. Else,
clarify. Thank you.
Aug-28-2020 07:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Apr/29/1966Enrollment Entry
3. Sex:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908088
Page 98 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-28-2020 07:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 07:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 07:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908089
Page 99 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 07:46:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908090
Page 100 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 07:46:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 07:46:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 07:46:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908091
Page 101 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 07:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:HYPOTHYROI
DISM
Start Date: UNK/UNK/201
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPOTHYROIDISMInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 07:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 07:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908092
Page 102 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Aug-28-2020 07:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:BENIGN PROSTAT
IC HYPERPLASIA
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BENIGN PROSTATIC HYPER
PLASIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 07:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 07:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908093
Page 103 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:49:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:HYPERCHOLES
TEROLEMIA
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:49:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:49:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 07:49:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 07:49:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 07:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908094
Page 104 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Hi
story Term:TORN ROTATOR C
UFF RIGHT SIDE
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TORN ROTATOR CUFF RIGH
T SIDEInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 07:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 07:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.e
Date Location User Value Reason
Aug-28-2020 07:52:08 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908095
Page 105 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Nu
mber:5
Medical Hist
ory Term:TORN MENISCU
S LEFT SIDE
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TORN MENISCUS LEFT SIDEInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2019Initial Entry
1.f
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908096
Page 106 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:TORN ROTATOR C
UFF LEFT SIDE
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TORN ROTATOR CUFF LEFT
SIDEInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 07:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 07:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.g
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908097
Page 107 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-28-2020 07:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical Hi
story Term
:ARTHROSCOPIC R
EPAIR LEFT SIDE
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ARTHROSCOPIC REPAIR LE
FT SIDEInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 07:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 07:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908098
Page 108 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h
Date Location User Value Reason
Aug-28-2020 07:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical Hi
story Term
:ROTATOR CUFF R
EPAIR RIGHT SIDE
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908099
Page 109 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROTATOR CUFF REPAIR RIG
HT SIDEInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-28-2020 07:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-28-2020 07:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.i
Date Location User Value Reason
Aug-28-2020 07:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical Hi
story Term:ROTATOR CUFF R
EPAIR LEFT SIDE
Start Date: UNK/UNK/2015Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908100
Page 110 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/2015
1.i Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROTATOR CUFF REPAIR LEF
T SIDEInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-28-2020 07:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-28-2020 07:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908101
Page 111 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
160.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.8Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908102
Page 112 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 08:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908103
Page 113 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 08:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 08:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Transcription Error
Aug-28-2020 08:02:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Randomization Date
28/Aug/2020 is
before or more than
1 day after
corresponding Date
of Visit 26/Aug
/2020. Please review
and update as
appropriate.
Aug-28-2020 08:02:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 08:02:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
242502Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908104
Page 114 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 08:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 08:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 14:17:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 03:30:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908105
Page 115 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-01-2020 14:22:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
not enough serum for vile 5Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 14:17:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3MGZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 14:17:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3MGZInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 14:17:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3MH0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 14:17:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3MH0Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020 14:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3MH1Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908106
Page 116 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 14:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3MH1Initial Entry
5.d
Date Location User Value Reason
Sep-01-2020 14:22:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLCY8Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 14:22:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLCY8Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908107
Page 117 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 08:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 08:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 14:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 03:30:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908108
Page 118 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-01-2020 14:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5R8WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 14:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5R8WInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908109
Page 119 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 18:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0908110
Page 120 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 08:03:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908111
Page 121 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 08:03:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908112
Page 122 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020 06:15:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-08-2020 10:13:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Oct-08-2020 06:53:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened PDQ RQ2: As per
your response,
DELAY CRITERIA
WAS MET AND A
DEVIATIONWAS
SUBMITTED - there
is delay in
vaccination hence
please consider to
update corresponding
delay details of
vaccination form.
Else clarify.
Oct-07-2020 09:34:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered not delayed due to
temperature
Oct-07-2020 06:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened PDQ RQ1: As per
your response,
DELAY CRITERIA
WAS MET. Thus,
please confirm
whether
corresponding temp.
delay details can be
updated on
Vaccination form
(either V1 or V2) as
appropriate. Else
clarify.
Oct-06-2020 09:54:34 ACV0PFEINFP6000 Query 2: Answered DELAY CRITERIA
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0908113
Page 123 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)WAS MET AND A
DEVIATIONWAS
SUBMITTED
Oct-06-2020 04:47:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (14 day)
from DOV (26/Aug
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Oct-03-2020 02:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-02-2020 12:26:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-02-2020 12:26:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
Sep-24-2020 23:51:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal Swab,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908114
Page 124 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2.a
Date Location User Value Reason
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 96.8
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-03-2020 02:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation
Oct-02-2020 12:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.8 F
is outside of Normal
Range 97 - 99.5 F.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908115
Page 125 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 12:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908116
Page 126 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 12:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 12:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 12:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 12:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 12:27:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 12:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5PYHInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908117
Page 127 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 12:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5PYHInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908118
Page 128 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 10:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 10:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Sep/14/2020
Reason(s) for Temporary Dela
y of Vaccination
ANTICIPATED NON-STU
DY VACCINATIONTranscription Error
Oct-08-2020 10:10:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Was there a
temporary delay of
vaccination?' is
marked as Yes and
'Date of First Delay'
is not entered.
Please review and
update as
appropriate.
Oct-08-2020 10:10:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Reason(s) for Temporary Dela
y of Vaccination
ANTICIPATED NON-STU
DY VACCINATIONTranscription Error
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908119
Page 129 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020 09:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908120
Page 130 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-02-2020 12:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908121
Page 131 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 10:07:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908122
Page 132 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 12:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 12:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 12:15:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 12:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 12:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 12:15:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZF1RInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908123
Page 133 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 12:15:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKZF1RInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 12:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZF1SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 12:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKZF1SInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020 12:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRD7TDInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 12:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRD7TDInitial Entry
5.d
Date Location User Value Reason
Oct-30-2020 12:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRD7TFInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908124
Page 134 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 12:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRD7TFInitial Entry
5.e
Date Location User Value Reason
Oct-30-2020 12:18:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRD7TGInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-30-2020 12:18:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRD7TGInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908125
Page 135 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020 10:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020 10:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020 10:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908126
Page 136 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908127
Page 137 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908128
Page 138 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908129
Page 139 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908130
Page 140 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908131
Page 141 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908132
Page 142 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908133
Page 143 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908134
Page 144 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908135
Page 145 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-28-2020 11:44:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908136
Page 146 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Oct-28-2020
23:33:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Oct-28-2020
11:45:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dUpdated
Oct-27-2020
23:51:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Rei
ssued:
Opene
dClinical - please record the
Fractures as adverse events
on the AE CRF
Oct-27-2020
12:14:05
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
3: An
swere
dthis is an SAE and the
subject was hospitalized
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908137
Page 147 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
Oct-26-2020
16:48:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Rei
ssued:
Opene
dClinical Per Protocol
sections 10.3.1 and 10.3.3,
all non-serious AEs are
recorded on the AE CRF,
and are defined as ‘any
untoward medical
occurrence temporally
associated with drug
administration' (to V3 for
AEs).
Oct-23-2020
16:41:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dwill be added as required
Oct-23-2020
15:36:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedClinical SAE report
includes additional trauma
with fractures of 4 ribs,
scapula and inf pubic
ramus; please review for
safety relevance and update
AE form with these events
if appropriate
Oct-02-2020
07:07:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Oct-01-2020
11:06:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dfollow up form was faxed
yesterday to reflect change
Oct-01-2020
05:50:31
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020375982,
the term in AE CRF was
updated to
'SUBARACHNOID
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908138
Page 148 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) HEMORRAGE' while
retained as Head Injury in
SDB. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Sep-30-2020
16:17:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Sep-30-2020
15:13:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple concepts in the
term HEAD INJURY
FROM FALL. Please split
the term into HEAD
INJURY and FALL and
submit separately. Thank
you.
Sep-30-2020
14:59:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
SUB
ARA
CHN
OID
HEM
ORR
AGENew Information
Sep-30-2020
13:17:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
HEA
D INJ
URY
FRO
M FA
LLTranscription Error
Sep-28-2020
16:05:48
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data
Entry
:
HEA
D INJInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908139
Page 149 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) URY
4. Start Date Time:
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 09:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/8/2020 UNK:UNKNew Information
Sep-30-2020 15:02:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/8/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 19:55:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-06-2020 13:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Transcription Error
Oct-06-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-06-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Transcription Error
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908140
Page 150 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020 19:04:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
SUBARACHNOID
HEMORRAGE :
Please can you
review the toxicity
grade for this AE as
currently it pertains
to not interfering with
subjects' usual
participation? Thanks
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 13:54:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed SAE closed; will
follow for SAE
update with the
COVID testing info
reported here
Oct-23-2020 16:26:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered per subject no covid
test - SAE will be
updated
Oct-23-2020 15:37:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020375982] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908141
Page 151 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-29-2020 05:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE HEAD
INJURY: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908142
Page 152 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-02-2020 00:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query.
Oct-01-2020 11:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered DONE
Oct-01-2020 04:43:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please refer
CRF Completion
Guidelines Section
8.46.2.2 and add an
AE with the AE
Term as fall, Thank
you.
Sep-30-2020 13:17:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-30-2020 13:17:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
FALLTranscription Error
Sep-29-2020 03:25:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: As per CRF
Completion
Guidelines Section
8.46.2.2. Fall as
well as the Injury
due to the fall need
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908143
Page 153 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
to be recorded as
two separate
Adverse Event.
Please consider
updating another
AE with the term
Fall, Thank you.
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
FALL FROM BICYCLEInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 03:22:39 ACV0PFEINFP6000 Query 4: Closed sdb outcome updated
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0908144
Page 154 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)
Mar-01-2021 03:50:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Candidat
ePending SDB update
Feb-26-2021 07:29:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Form submitted
Feb-26-2021 00:39:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened SAE RECON 1:outcome
was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
confirm if follow up AEM
form was submitted to
update outcome in Safety
database
Feb-25-2021 13:52:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Changed data per query
Feb-23-2021 20:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened SAE
RECON:AER#2020375982
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
confirm correct outcome.If
safety update is required,
please submit a ffup form.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908145
Page 155 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021
09:53:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Feb-22-2021
09:53:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDNew Information
Feb-22-2021
09:53:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE SUBARACHNOID
HEMORRAGE : Response to "What
was the outcome of this adverse
event?" is 'Recovering/Resolving'
but AE End Date/Time is present.
Sep-30-2020
21:59:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Sep-30-2020
15:02:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-30-2020
15:01:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE SUBARACHNOID
HEMORRAGE : Response to "What
was the outcome of this adverse
event?" is 'Recovering/Resolving'
but AE End Date/Time is present.
Sep-30-2020
15:01:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908146
Page 156 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-30-2020
15:01:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RE
SOLVINGTranscription Error
Sep-29-2020
06:01:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020375982,outcome
was reported as
Recovering/Resolvingto Safety DB
however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Sep-28-2020
16:05:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020 16:05:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-29-2020 05:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020375982Initial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908147
Page 157 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
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
Oct-01-2020 12:51:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed bicycle information
in "Other cause'
section
Oct-01-2020 11:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Per CRF
Completion
guidelines Sect
8.49.2.2 ("record
fall from ladder")
please add detail on
where the fall
started (e.g. 'fall
from bicycle')
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FALLInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908148
Page 158 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020
23:44:40
(UTC-06:00)ACV0PFEINFP6000 Query 2:
ClosedResponse
satisfies query
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908149
Page 159 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US &
Canada)
Oct-27-2020
10:37:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredTranscription
Error
Oct-27-2020
10:37:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy treat
ment(s),
this even
t is due t
o:
OTHE
R
If Oth
er, spe
cify:
fall f
rom
bicy
cleTranscription
Error
Oct-26-2020
13:52:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Reissued:
OpenedClinical - the
original query
was
unfortunately
unclear; please
add 'from
bicycle' to AE
report of 'fall'
as the
causality (SAE
report does not
require a
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908150
Page 160 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
safety update)
Oct-23-2020
16:26:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answeredupdated SAE
form will be
sent
Oct-23-2020
15:35:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedClinical -
please expand
'Fall' with
report in SAE
of 'Fall from
bicycle'
Oct-10-2020
01:17:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Oct-09-2020
10:37:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Oct-09-2020
10:37:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy treat
ment(s),
this even
t is due t
o:
OTHE
R
If Oth
er, spe
cify:Transcription
Error
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908151
Page 161 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
fall
Oct-08-2020
13:58:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field [bicycle
accident]. Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. If this is
already in the
predefined list
above please
choose the
appropriate
value. Please
review and
update as
necessary.
Oct-01-2020
11:08:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy treat
ment(s),
this even
t is due t
o:
OTHE
RInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908152
Page 162 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Oth
er, spe
cify:
BIC
YC
LE
AC
CID
EN
T
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020 11:08:09
(UTC-06:00) Central
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
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908153
Page 163 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020 11:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908154
Page 164 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
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
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left frontal lobe contusionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908155
Page 165 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
fall from bicycleTranscription Error
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908156
Page 166 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 11:21:14
(UTC-06:00) Central
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
Oct-28-2020 11:21:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908157
Page 167 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
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
Nov-03-2020 12:37:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 2: Closed Response satisfies
query
Nov-03-2020 10:43:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered confirmed subject
did not meet
temporary delay at
v2
Nov-02-2020 19:20:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery: Acute
Pain hip right side:
Please can you
confirm if subject
DID or DID NOT
meet TDV criteria as
a result of this AE
ongoing at V2?
Thanks
Oct-29-2020 15:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-29-2020 15:10:39
(UTC-06:00) CentralACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908158
Page 168 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Oct-29-2020 15:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute Pain hip right sideNew Information
Oct-29-2020 08:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened ClinQuery:Acute
Pain: please can you
update the verbatim
term to include the
location of this AE?
Thanks
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908159
Page 169 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:28:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallTranscription Error
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
CONCOMITANT DRUG TRE
ATMENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908160
Page 170 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 11:24:18
(UTC-06:00) Central
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
Oct-28-2020 11:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908161
Page 171 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
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
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Decreased MobilityInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 10:08:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/20/2020 UNK:UNKNew Information
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908162
Page 172 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:29:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallTranscription Error
Oct-28-2020 11:28:04
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0908163
Page 173 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Fall
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-30-2020 10:09:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-30-2020 10:09:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-30-2020 10:08:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Decreased
Mobility : Response to
"What was the
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908164
Page 174 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-28-2020 11:28:04
(UTC-06:00) Central
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
Oct-28-2020 11:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908165
Page 175 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
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
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Closed Fracture of Rt Interior Pubi
c RamusInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908166
Page 176 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-29-2020 15:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-29-2020 15:13:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 15:13:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Transcription Error
Oct-29-2020 08:35:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened ClinQuery:Closed
Fracture of Rt
Interior Pubic Ramus
:please can you
review the toxicity
grade of this AE as
currently it pertains
to 'not interfering
with subjects' usual
function' . Thanks
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0908167
Page 177 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908168
Page 178 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 11:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908169
Page 179 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
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
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Closed Fracture of Four RibsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908170
Page 180 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-29-2020 15:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-29-2020 15:13:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 15:13:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Transcription Error
Oct-29-2020 08:35:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened ClinQuery:Closed
Fracture of Four
Ribs :please can you
review the toxicity
grade of this AE as
currently it pertains
to 'not interfering
with subjects' usual
function' . Thanks
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908171
Page 181 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908172
Page 182 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-28-2020 11:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908173
Page 183 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
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
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Closed Displaced Fracture of body
Right ScapulaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 10:10:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/20/2020 UNK:UNKNew Information
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908174
Page 184 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 15:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-29-2020 15:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 15:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Transcription Error
Oct-29-2020 08:35:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened ClinQuery:Closed
Displaced Fracture
of body Right
Scapula :please can
you review the
toxicity grade of this
AE as currently it
pertains to 'not
interfering with
subjects' usual
function' . Thanks
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908175
Page 185 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908176
Page 186 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-30-2020 10:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-30-2020 10:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-30-2020 10:10:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Closed
Displaced Fracture of
body Right Scapula :
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-28-2020 11:39:30
(UTC-06:00) Central
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
Oct-28-2020 11:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908177
Page 187 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
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-30-2020 04:09:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-29-2020 15:38:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered unspecified location
Oct-29-2020 08:36:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened ClinQuery:Muscle
Spasm : please can
you update to include
the location of this
AE? Thanks
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Muscle SpasmInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908178
Page 188 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 15:14:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Transcription Error
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908179
Page 189 of 202
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421166 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Bicycle FallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 11:43:20
(UTC-06:00) Central
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
090177e196ae3e41\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0908180
Page 190 of 202
***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:
…[truncated]