Document text
Page 1 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 10421259 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908866
Page 2 of 144
***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: 10421259 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
Oct/5/2020
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908867
Page 3 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10421259]
2.Birth Date: /1973
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908868
Page 4 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908869
Page 5 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 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
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908870
Page 6 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908871
Page 7 of 144
***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: 10421259 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:[Allergic Rhinitis]
Start Date: UNK/UNK/1988
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis (Pollen)]
Start Date: UNK/UNK/1988
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heartburn]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908872
Page 8 of 144
***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: 10421259 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:[Irritable Bowel Syndrome]
Start Date: Jan/UNK/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Caesarean Section]
Start Date: Apr/3/2007
Ongoing: NO
End Date:
Apr/3/2007
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Implants insertion]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Implant Removal]
Start Date: Sep/16/2019
Ongoing: NO
End Date:
Sep/16/2019
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908873
Page 9 of 144
***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: 10421259 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:[Hernia Procedure]
Start Date: Apr/27/2002
Ongoing: NO
End Date:
Apr/27/2002
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to dust]
Start Date: UNK/UNK/1988
Ongoing: YES
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908874
Page 10 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908875
Page 11 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
2.Weight: [115.0]
3.Unit: LB
4.Height: [60.0]
5.Unit: in
6.Body Mass Index: [22.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908876
Page 12 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908877
Page 13 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/5/2020
2.Randomization Number: [94394]
3.Randomization Group: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908878
Page 14 of 144
***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: 10421259 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:
Oct/5/2020
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 [BPBYLN]
5.bSample ID [BPBYLP]
5.cSample ID [BPBYLR]
5.dSample ID [BPLD5T]
5.eSample ID [BPLD5V]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908879
Page 15 of 144
***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: 10421259 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/5/2020
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 [BN5PYS]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908880
Page 16 of 144
***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: 10421259 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: Oct/5/2020 16:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908881
Page 17 of 144
***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: 10421259 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
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908882
Page 18 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908883
Page 19 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908884
Page 20 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/26/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908885
Page 21 of 144
***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: 10421259 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/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 [BN5PZG]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908886
Page 22 of 144
***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: 10421259 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: Oct/26/2020 12:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908887
Page 23 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908888
Page 24 of 144
***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: 10421259 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:
Nov/24/2020
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 [BN5CX5]
5.bSample ID [BKZF5L]
5.cSample ID [BKZF5M]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908889
Page 25 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908890
Page 26 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908891
Page 27 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908892
Page 28 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908893
Page 29 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908894
Page 30 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908895
Page 31 of 144
***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: 10421259 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:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908896
Page 32 of 144
***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: 10421259 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: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908897
Page 33 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908898
Page 34 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908899
Page 35 of 144
***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: 10421259 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?
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908900
Page 36 of 144
***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: 10421259 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:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908901
Page 37 of 144
***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: 10421259 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:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908902
Page 38 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908903
Page 39 of 144
***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: 10421259 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:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908904
Page 40 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908905
Page 41 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908906
Page 42 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908907
Page 43 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 ENLARGED LYMPHNO
DES LEFT AXILLA Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 PAIN AT INJECTION SIT
E Oct/6/2020 U
NK:UNK NO
End Date Time:
Oct/7/2020 UNK:
UNK
Repeating
Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908908
Page 44 of 144
***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: 10421259 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)[ENLARGED LYMPHNODES LEFT AXILLA]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 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
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908909
Page 45 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
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[ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908910
Page 46 of 144
***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: 10421259 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)[PAIN AT INJECTION SITE]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 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
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908911
Page 47 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
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[ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908912
Page 48 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908913
Page 49 of 144
***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: 10421259 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[ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908914
Page 50 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908915
Page 51 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 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.Date: //
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908916
Page 52 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908917
Page 53 of 144
***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: 10421259 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?
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908918
Page 54 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908919
Page 55 of 144
***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: 10421259 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?
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908920
Page 56 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908921
Page 57 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908922
Page 58 of 144
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908923
Page 59 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908924
Page 60 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10421259 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:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908925
Page 61 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908926
Page 62 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 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?
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908927
Page 63 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908928
Page 64 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908929
Page 65 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908930
Page 66 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908931
Page 67 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908932
Page 68 of 144
***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: 10421259 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 [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908933
Page 69 of 144
***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: 10421259 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: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908934
Page 70 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908935
Page 71 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908936
Page 72 of 144
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908937
Page 73 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908938
Page 74 of 144
***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: 10421259 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: [ ]
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908939
Page 75 of 144
***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: 10421259 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 Nov/24/2020
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908940
Page 76 of 144
***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: 10421259 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
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908941
Page 77 of 144
***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: 10421259 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 Jan-21-2021 12:05:48 (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.
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908942
Page 78 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-06-2020 09:55:18 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908943
Page 79 of 144
***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: 10421259 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 Jan-21-2021 12:05:48 (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 Nov-24-2020 15:27:40 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Seger Approved Nov-10-2020 16:51:23 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSeger, 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.
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908944
Page 80 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 10421259 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
Oct-06-2020 09:53:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-06-2020 09:53:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908945
Page 81 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-06-2020 09:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Oct/5/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908946
Page 82 of 144
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020 09:52:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10421259Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-06-2020 09:52:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-06-2020 09:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-06-2020 09:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-06-2020 09:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e42\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-2021-5683-0908947
Page 83 of 144
***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: 10421259 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-06-2020 09:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908948
Page 84 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 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-06-2020 09:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 09:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020 09:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908949
Page 85 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-06-2020
16:12:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Allergic
Rhinitis
Start Date: UNK/UN
K/1988
Ongoing: YESTranscription
Error
Oct-06-2020
10:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:Allergic Rh
initis (Dust)
Start Date: UNK/UNK
/1988
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:01:29
(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
Oct-06-2020
19:14:00
(UTC-06:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1
: ClosedDiscrepancy
has been
closed.
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908950
Page 86 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US &
Canada)
Oct-06-2020
16:12:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription
Error
Oct-06-2020
16:12:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Allergic
RhinitisTranscription
Error
Oct-06-2020
12:18:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1
: Opene
dMultiple
concepts in
the term
ALLERGIC
RHINITIS
(DUST).
Split the term
into
ALLERGIC
RHINITIS
and
ALLERGY
TO DUST
and report as
two separate
entries.
Thank you.
Oct-06-2020
10:01:29
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data E
ntry:
Allergic
Rhinitis
(Dust)Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908951
Page 87 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
1.a Start Date:
Date Location User Value Reason
Oct-06-2020 10:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-06-2020 10:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-06-2020 10:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Allergic Rhini
tis (Pollen)
Start Date: UNK/UNK/1
988
Ongoing: YESInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908952
Page 88 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:02:02
(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
Oct-06-2020 10:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic Rhinitis (Pollen)Initial Entry
1.b Start Date:
Date Location User Value Reason
Oct-06-2020 10:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-06-2020 10:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-06-2020 10:02:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term
:Gastroesophage
al Reflux Disea
seInitial Entry
090177e196ae3e42\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-2021-5683-0908953
Page 89 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/201
9
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:02:29
(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
Oct-06-2020 10:02:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gastroesophageal Reflux Di
seaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-06-2020 10:02:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-06-2020 10:02:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-06-2020 10:03:32 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e42\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-2021-5683-0908954
Page 90 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Num
ber:4
Medical Histor
y Term:Heartburn
Start Date: UNK/UNK
/2019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:03:32
(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
Oct-06-2020 10:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HeartburnInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-06-2020 10:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-06-2020 10:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e42\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-2021-5683-0908955
Page 91 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e
Date Location User Value Reason
Oct-06-2020
16:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Irritable Bo
wel Syndro
me
Start Date: Jan/UNK/20
20
Ongoing: YESNew Information
Oct-06-2020
10:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Irritable Bo
wel Syndro
me
Start Date: UNK/UNK/
2020
Ongoing: YESTranscription
Error
Oct-06-2020
10:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Irritable Bo
wel Syndro
me
Start Date: Oct/5/2020
Ongoing: YESInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908956
Page 92 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:04:03
(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
Oct-06-2020 10:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Irritable Bowel SyndromeInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-07-2020
02:44:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-06-2020
16:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Oct-06-2020
16:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020New Information
Oct-06-2020
10:37:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dStart Date is after
or equal to the
first vaccination
date 05/Oct/2020.
Please review and
update as
appropriate.
090177e196ae3e42\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-2021-5683-0908957
Page 93 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-06-2020
10:16:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-06-2020
10:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Transcription
Error
Oct-06-2020
10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the
first vaccination
date 05/Oct/2020.
Please review and
update as
appropriate.
Oct-06-2020
10:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-06-2020 10:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-06-2020 10:05:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histo
ry Term:Caesarean S
ection
Start Date: Apr/3/2007Initial Entry
090177e196ae3e42\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-2021-5683-0908958
Page 94 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
Apr/3/20
07
1.f Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:05:05
(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
Oct-06-2020 10:05:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Caesarean SectionInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-06-2020 10:05:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/3/2007Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-06-2020 10:05:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/3/2007Initial Entry
1.g
090177e196ae3e42\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-2021-5683-0908959
Page 95 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-06-2020
16:14:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:Breast Impla
nts insertion
Start Date
:UNK/UNK/2
004
Ongoing: NO
End Date:
UNK/UN
K/2004Transcription
Error
Oct-06-2020
10:05:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Breast Impl
ants
Start Date: UNK/UNK/
2004
Ongoing: NO
End Date:
UNK/U
NK/200
4Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908960
Page 96 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:05:36
(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
Oct-06-2020
19:14:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1
: ClosedDiscrepancy
has been
closed.
Oct-06-2020
16:14:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription
Error
Oct-06-2020
16:14:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Breast I
mplants
insertio
nTranscription
Error
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908961
Page 97 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Oct-06-2020
12:19:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify
BREAST
IMPLANTS as
follows...Device
only term. Are
you reporting
INSERTION?
REMOVAL?
INFECTION
OF? Other?
Please update
the verbatim
term to further
specify. Thank
you.
Oct-06-2020
10:05:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Breast
Impla
ntsInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-06-2020 10:05:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0908962
Page 98 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-06-2020 10:05:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.h
Date Location User Value Reason
Oct-06-2020 10:06:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Breast Implant
Removal
Start Date: Sep/16/2019
Ongoing: NO
End Date:
Sep/16/201
9Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908963
Page 99 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:06:09
(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
Oct-06-2020 10:06:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Breast Implant RemovalInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-06-2020 10:06:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-06-2020 10:06:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/16/2019Initial Entry
1.i
Date Location User Value Reason
Oct-06-2020 10:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9Initial Entry
090177e196ae3e42\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-2021-5683-0908964
Page 100 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:Hernia Proc
edure
Start Date: Apr/27/2002
Ongoing: NO
End Date:
Apr/27/2
002
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908965
Page 101 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:06:43
(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
Oct-06-2020 10:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Hernia ProcedureInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-06-2020 10:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/27/2002Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-06-2020 10:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/27/2002Initial Entry
1.j
Date Location User Value Reason
Oct-06-2020 16:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10Initial Entry
090177e196ae3e42\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-2021-5683-0908966
Page 102 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:allergy to d
ust
Start Date: UNK/UNK
/1988
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Oct-06-2020 16:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020
16:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergy to dustInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-06-2020
16:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-06-2020
16:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e42\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-2021-5683-0908967
Page 103 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-06-2020 10:10:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908968
Page 104 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
115.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
60.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
090177e196ae3e42\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-2021-5683-0908969
Page 105 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Mass Index:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.5Initial Entry
7.a
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 98.4
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-06-2020 10:11:00 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e42\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)
(6)
FDA-CBER-2021-5683-0908970
Page 106 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)F
7.a Temperature Location:
Date Location User Value Reason
Oct-06-2020 10:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908971
Page 107 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908972
Page 108 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-06-2020 10:11:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908973
Page 109 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-06-2020 10:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-06-2020 10:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
94394Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908974
Page 110 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:12:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:12:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 10:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020 10:12:34
(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-06-2020 10:12:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908975
Page 111 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-06-2020 10:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPBYLNInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 10:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPBYLNInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 10:13:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPBYLPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 10:13:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPBYLPInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 10:13:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPBYLRInitial Entry
090177e196ae3e42\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-2021-5683-0908976
Page 112 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 10:13:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPBYLRInitial Entry
5.d
Date Location User Value Reason
Oct-06-2020 10:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLD5TInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 10:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLD5TInitial Entry
5.e
Date Location User Value Reason
Oct-06-2020 10:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLD5VInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-06-2020 10:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLD5VInitial Entry
090177e196ae3e42\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-2021-5683-0908977
Page 113 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:14:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:14:35
(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-06-2020 10:14:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020 10:14:35
(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-06-2020 10:14:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908978
Page 114 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-06-2020 10:14:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5PYSInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 10:14:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5PYSInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908979
Page 115 of 144
***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: 10421259 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-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 10:12:13
(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-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020 16:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908980
Page 116 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Side:
Date Location User Value Reason
Oct-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020 10:12:13
(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
Oct-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION 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-06-2020 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908981
Page 117 of 144
***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: 10421259 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
Oct-15-2020
02:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-14-2020
11:58:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-14-2020
11:58:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUBJ
ECTTranscription
Error
Oct-14-2020
05:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Per Trial
Max, Subject is
not the subset of
'Reactogenicity
Diary collection'.
Please review and
consider to update
response for
'Reactogenicity
diary collection' as
'No', else clarify
in query response.
Thanks.
Oct-06-2020
10:12:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICI
TY E-DIARY COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3e42\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) (6)
FDA-CBER-2021-5683-0908982
Page 118 of 144
***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: 10421259 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-28-2020 13:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908983
Page 119 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020 13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
2.a
Date Location User Value Reason
Oct-28-2020 13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 96.9
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-28-2020 13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-31-2020
02:40:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 ACV0PFEINFP6000 Query 1: Answered not clinically
090177e196ae3e42\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-2021-5683-0908984
Page 120 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
08:15:15
(UTC-06:00) Central
Time (US & Canada)significant
Oct-30-2020
01:42:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dDM: Response
does not resolve
the query. Kindly
confirm if 96.9 F
is clinically
significant or
Non-clinically
significant.
Thanks.
Oct-29-2020
09:55:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-29-2020
09:44:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Reissued:Opene
dKindly verify and
confirm NCS or
NS. Thank you.
Oct-28-2020
13:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-28-2020
13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.9
F is outside of
Normal Range 97
- 99.5 F.
Oct-28-2020
13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.9Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3e42\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-2021-5683-0908985
Page 121 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-28-2020 13:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908986
Page 122 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908987
Page 123 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-28-2020 13:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908988
Page 124 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 13:28:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 13:28:40
(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-28-2020 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020 13:28:40
(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-28-2020 13:28:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908989
Page 125 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-28-2020 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5PZGInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5PZGInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908990
Page 126 of 144
***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: 10421259 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-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020 13:29:26
(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-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020 12:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908991
Page 127 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Body Side:
Date Location User Value Reason
Oct-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-28-2020 13:29:26
(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
Oct-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION 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-28-2020 13:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908992
Page 128 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020
15:27:40 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908993
Page 129 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 15:27:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 15:27:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
15:28:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
15:27:54
(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.
Nov-24-2020
15:27:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/24/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908994
Page 130 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Nov-24-2020
15:28:11 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5CX5Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
15:28:11 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN5CX5Initial Entry
5.b
Date Location User Value Reason
Nov-24-2020
15:28:29 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZF5LInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020
15:28:29 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BKZF5LInitial Entry
5.c
Date Location User Value Reason
Nov-24-2020
15:28:42 (UTC-06:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZF5MInitial Entry
090177e196ae3e42\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-2021-5683-0908995
Page 131 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US &
Canada)
5.c Sample ID
Date Location User Value Reason
Nov-24-2020
15:28:42 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BKZF5MInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908996
Page 132 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908997
Page 133 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908998
Page 134 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:28:38
(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-12-2020 10:28:38
(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 Value Reason
Oct-12-2020
10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ENLARGED LYMPHNO
DES LEFT AXILLAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020
10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
10:28:38ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e42\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-2021-5683-0908999
Page 135 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)End Date Time:
Oct/7/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
10:28:38
(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-12-2020
10:28:38
(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-12-2020
10:28:38
(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
090177e196ae3e42\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-2021-5683-0909000
Page 136 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020
10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
10:28:38
(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-12-2020
10:28:38
(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-12-2020
10:28:38
(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-12-2020
10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e42\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-2021-5683-0909001
Page 137 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-12-2020
10:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909002
Page 138 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:30:35
(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-12-2020 10:30:35
(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-12-2020
10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020
10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
10:30:35ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e42\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-2021-5683-0909003
Page 139 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)End Date Time:
Oct/7/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
10:30:35
(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-12-2020
10:30:35
(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-12-2020
10:30:35
(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
090177e196ae3e42\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-2021-5683-0909004
Page 140 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020
10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
10:30:35
(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-12-2020
10:30:35
(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-12-2020
10:30:35
(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-12-2020
10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e42\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-2021-5683-0909005
Page 141 of 144
***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: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-12-2020
10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909006
Page 142 of 144
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 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
Nov-24-2020
15:28:59 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-24-2020 15:28:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-24-2020
15:28:59 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909007
Page 143 of 144
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-24-2020 15:28:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-06-2020 10:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Oct-06-2020 09:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-24-2020 15:28:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/24/2020Initial Entry
Oct-06-2020 10:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Oct-06-2020 09:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909008
Page 144 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421259 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 16:21:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e42\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909009