125742 S1 M5 CRF c4591001 1101 11011115

Document text

Page 1 of 181
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973787
Page 2 of 181
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973788
Page 3 of 181
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11011115]
2.Birth Date: /1989
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973789
Page 4 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973790
Page 5 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973791
Page 6 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973792
Page 7 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[high cholesterol]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[type two diabetes mellitus]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar bulging disc]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thoracic bulging disc]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973793
Page 8 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pepperoni allergy]
Start Date: UNK/UNK/1989
Ongoing: YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973794
Page 9 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973795
Page 10 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [88.65]
3.Unit: kg
4.Height: [164.75]
5.Unit: cm
6.Body Mass Index: [32.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973796
Page 11 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/20/2020
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:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973797
Page 12 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [110270]
3.Randomization Group: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973798
Page 13 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BPT6PH]
5.bSample ID [BPT6PJ]
5.cSample ID [BPT6PK]
5.dSample ID [BRTNWW]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973799
Page 14 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BPT6NS]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973800
Page 15 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/20/2020 15:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973801
Page 16 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973802
Page 17 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973803
Page 18 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973804
Page 19 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973805
Page 20 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM5JD9]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973806
Page 21 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/12/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973807
Page 22 of 181
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973808
Page 23 of 181
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
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 [BS83DK]
5.bSample ID [BGHD48]
5.cSample ID [BGHD47]
5.dSample ID [BGHD46]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973809
Page 24 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973810
Page 25 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973811
Page 26 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973812
Page 27 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973813
Page 28 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973814
Page 29 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973815
Page 30 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973816
Page 31 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973817
Page 32 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973818
Page 33 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973819
Page 34 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973820
Page 35 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973821
Page 36 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973822
Page 37 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973823
Page 38 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973824
Page 39 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973825
Page 40 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  sinus congestion  Oct/21/2020 UNK:
UNK NO
End Date Time:
Oct/23/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  headache  Oct/21/2020 UNK:
UNK NO
End Date Time:
Oct/23/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  genital herpes  Nov/9/2020 UNK:
UNK YES  Repeating
Pages
 4.ADVERSE EV
ENT 4  infection of coxsacki
evirus Dec/6/2020 UNK:
UNK NO
End Date Time:
Dec/15/2020 11:58
 Repeating
Pages
 5.ADVERSE EV
ENT 5  exposure during preg
nancy Dec/19/2020 UNK:
UNK YES  Repeating
Pages
 6.ADVERSE EV
ENT 6  spontaneous abortion
 Feb/20/2021 UNK:
UNK NO
End Date Time:
Feb/20/2021 UNK:UNK
 Repeating
Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973826
Page 41 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[sinus congestion]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/23/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973827
Page 42 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973828
Page 43 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[headache]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/23/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973829
Page 44 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973830
Page 45 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[genital herpes]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[genital sexually transmitted disease not related to IP]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973831
Page 46 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973832
Page 47 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[infection of coxsackievirus]
4.Start Date Time: Dec/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 11:58
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[other viral infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973833
Page 48 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973834
Page 49 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[exposure during pregnancy]
4.Start Date Time: Dec/19/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Intercourse]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973835
Page 50 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973836
Page 51 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[spontaneous abortion]
4.Start Date Time: Feb/20/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/20/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973837
Page 52 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown, but subject has a history or pregnancy complications]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO Comments
12.Was a Non-Drug Treatment given? NO Comments
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[2021107155]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973838
Page 53 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973839
Page 54 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973840
Page 55 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973841
Page 56 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: //
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973842
Page 57 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973843
Page 58 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973844
Page 59 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973845
Page 60 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973846
Page 61 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973847
Page 62 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973848
Page 63 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973849
Page 64 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973850
Page 65 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973851
Page 66 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973852
Page 67 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973853
Page 68 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973854
Page 69 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973855
Page 70 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973856
Page 71 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973857
Page 72 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973858
Page 73 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973859
Page 74 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973860
Page 75 of 181
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973861
Page 76 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973862
Page 77 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973863
Page 78 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973864
Page 79 of 181
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973865
Page 80 of 181
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973866
Page 81 of 181
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973867
Page 82 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973868
Page 83 of 181
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Casebook Signature Form
1.Casebook Signature
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973869
Page 84 of 181
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973870
Page 85 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-20-2020 16:40:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973871
Page 86 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Feb-04-2021 12:01:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973872
Page 87 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
11Feb-26-2021 09:27:00 (UTC-06:00) Central Time
(US & Canada)
11Feb-24-2021 11:12:04 (UTC-06:00) Central Time
(US & Canada)The subject did not provide the information to the
research staff.
11Feb-24-2021 11:11:32 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973873
Page 88 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
12Feb-26-2021 09:42:03 (UTC-06:00) Central Time
(US & Canada)
12Feb-24-2021 11:12:54 (UTC-06:00) Central Time
(US & Canada)The subject did not report the information to the
research staff.
Unknown
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973874
Page 89 of 181
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-02-2021 17:04:43 (UTC-06:00) Central
Time (US & Canada)The subject was contacted on the date of this
visit. Due to unblinded availability, the subject
was unblinded on a later date.
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973875
Page 90 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973876
Page 91 of 181
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-20-2020 16:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-20-2020 16:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973877
Page 92 of 181
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-20-2020 16:40:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/20/2020Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973878
Page 93 of 181
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-20-2020 16:40:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11011115Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-20-2020 16:40:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-20-2020 16:40:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-20-2020 16:40:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-20-2020 16:40:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973879
Page 94 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 16:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973880
Page 95 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-20-2020 16:41:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 16:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 16:41:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973881
Page 96 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Oct-20-2020 16:41:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:high cholester
ol
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:41:27
(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-20-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
high cholesterolInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-20-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-20-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973882
Page 97 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-20-2020 16:41:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:type two diabetes
mellitus
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:41:48
(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-20-2020 16:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
type two diabetes mellitusInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-20-2020 16:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-20-2020 16:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-20-2020 16:42:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:lumbar bulging
discInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973883
Page 98 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Start Date: UNK/UNK/201
8
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:42:01
(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-20-2020 16:42:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar bulging discInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-20-2020 16:42:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-20-2020 16:42:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-20-2020 16:42:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History T
erm:thoracic bulging
disc
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973884
Page 99 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:42:13
(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-20-2020 16:42:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
thoracic bulging discInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-20-2020 16:42:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-20-2020 16:42:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-20-2020 16:42:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:anxiety
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973885
Page 100 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:42:28
(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-20-2020 16:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-20-2020 16:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-20-2020 16:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-21-2020 08:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:6
Medical History
Term:depression
Start Date: UNK/UNK/
2016
Ongoing: YESTranscription Error
Oct-20-2020 16:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973886
Page 101 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Medical History
Term:depression all
ergy
Start Date: UNK/UNK/2
016
Ongoing: YES
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973887
Page 102 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:42:38
(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-21-2020
10:34:56
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Oct-21-2020
08:34:10
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Oct-21-2020
08:34:10
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depressionTranscription
Error
Oct-21-2020
02:27:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opene
dClarify
DEPRESSION
ALLERGY as
follows...The
term is unclear.
Are you reporting
SEASONAL
DEPRESSION?
If so, update the
verbatim term as
such. If reporting
DEPRESSIVE
STATE and
ALLERGY, split
the current term
into
DEPRESSION
and ALLERGY
and submit
separately.
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0973888
Page 103 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Otherwise clarify
and edit the
verbatim
accordingly.
Thank you.
Oct-20-2020
16:42:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depression aller
gyInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-20-2020 16:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-20-2020 16:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-20-2020 16:42:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:pepperoni alle
rgy
Start Date: UNK/UNK/19
89
Ongoing: YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973889
Page 104 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Oct-20-2020 16:42:57
(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-20-2020 16:42:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pepperoni allergyInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-20-2020 16:42:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1989Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-20-2020 16:42:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973890
Page 105 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-20-2020 16:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973891
Page 106 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
88.65Initial Entry
3. Unit:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
164.75Initial Entry
5. Unit:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.7Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973892
Page 107 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-20-2020 16:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973893
Page 108 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-20-2020 16:46:20
(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-20-2020 16:46:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-20-2020 16:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-20-2020 16:46:20
(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-20-2020 16:46:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-20-2020 16:46:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973894
Page 109 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-20-2020 16:46:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-20-2020 16:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-20-2020 16:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973895
Page 110 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-20-2020 17:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-20-2020 17:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
110270Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973896
Page 111 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 17:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 17:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 17:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 17:26:22
(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-20-2020 17:26:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 17:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT6PHInitial Entry
5.a Sample ID
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973897
Page 112 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-20-2020 17:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT6PHInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 17:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT6PJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 17:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT6PJInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 17:27:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT6PKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 17:27:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT6PKInitial Entry
5.d
Date Location User Value Reason
Oct-20-2020 17:30:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTNWWInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973898
Page 113 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.d Sample ID
Date Location User Value Reason
Oct-20-2020 17:30:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTNWWInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973899
Page 114 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 17:21:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 17:21:06
(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-20-2020 17:21:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 17:20:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT6NSInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 17:20:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT6NSInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973900
Page 115 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020 16:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020 16:46:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020 16:46:42
(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-20-2020 16:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 15:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020 16:46:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-20-2020 16:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973901
Page 116 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Oct-20-2020 16:46:42
(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-20-2020 16:46:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-20-2020 16:46:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973902
Page 117 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-20-2020 16:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973903
Page 118 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973904
Page 119 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2.a
Date Location User Value Reason
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973905
Page 120 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Nov-12-2020 14:11:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973906
Page 121 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973907
Page 122 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-12-2020 14:10:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973908
Page 123 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 14:15:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 14:15:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 14:16:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 14:15:52
(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-12-2020 14:15:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 14:16:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM5JD9Initial Entry
5.a Sample ID
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973909
Page 124 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Nov-12-2020 14:16:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM5JD9Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973910
Page 125 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020 09:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973911
Page 126 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Nov-12-2020 14:11:35
(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
Nov-12-2020 14:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-12-2020 14:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973912
Page 127 of 181
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-10-2020 14:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973913
Page 128 of 181
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 14:20:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 14:20:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020 14:20:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020 14:20:03
(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.
Dec-10-2020 14:20:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-10-2020 14:20:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS83DKInitial Entry
5.a Sample ID
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973914
Page 129 of 181
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Dec-10-2020 14:20:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS83DKInitial Entry
5.b
Date Location User Value Reason
Dec-10-2020 14:33:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BGHD48Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-10-2020 14:33:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BGHD48Initial Entry
5.c
Date Location User Value Reason
Dec-10-2020 14:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BGHD47Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-10-2020 14:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BGHD47Initial Entry
5.d
Date Location User Value Reason
Dec-10-2020 14:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BGHD46Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973915
Page 130 of 181
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.d Sample ID
Date Location User Value Reason
Dec-10-2020 14:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BGHD46Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973916
Page 131 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Oct-21-2020 10:03:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973917
Page 132 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Oct-21-2020 19:21:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973918
Page 133 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973919
Page 134 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973920
Page 135 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973921
Page 136 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973922
Page 137 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 10:03:13
(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-21-2020 10:03:13
(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-26-2020 13:43:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Nasal Congestion is
listed under Section
8.1 as a Secondary
Symptom, which is
up to PI judgement.
Oct-26-2020 13:07:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Sinus congestion is
not listed as one of
the reportable
COVID-related
symptoms. Per
section 8.13, the PI
evaluated and stated
an illness visit was
not required.
Oct-22-2020 11:44:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Pease
confirm if SINUS
CONGESTION
could be a COVID
infection related
symptom. If it’s the
case, Please consider
conducting a COVID
related illness visit
and swab collection
as soon as possible.
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0973923
Page 138 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
sinus congestionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-30-2020 14:55:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-30-2020 14:10:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-30-2020 14:10:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/23/2020 UNK:UNKNew Information
Nov-30-2020 10:59:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine if
this Adverse Event is
still ONGOING as it
has been 40 days
since Onset Date.
Please update or
confirm.
Oct-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-21-2020 19:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973924
Page 139 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-21-2020 10:03:13
(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-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 19:21:17
(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-21-2020 10:03:13
(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-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973925
Page 140 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-21-2020 10:03:13
(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
Nov-30-2020 14:11:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-30-2020 14:11:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDTranscription Error
Nov-30-2020 14:10:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE sinus
congestion:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020 10:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973926
Page 141 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 19:21:42
(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-21-2020 19:21:42
(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-26-2020 13:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 13:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered headache is not listed
as one of the
reportable COVID-
related symptoms.
Per section 8.13, the
PI evaluated and
stated an illness visit
was not required.
Oct-23-2020 08:19:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Pease
confirm if
HEADACHE could
be a COVID
infection related
symptom. If it’s the
case, Please consider
conducting a COVID
related illness visit
and swab collection
as soon as possible.
Oct-21-2020 19:21:42
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
headacheInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973927
Page 142 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
4. Start Date Time:
Date Location User Value Reason
Oct-21-2020 19:21:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-30-2020 14:55:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-30-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-30-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/23/2020 UNK:UNKNew Information
Nov-30-2020 10:59:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine if
this Adverse Event is
still ONGOING as it
has been 40 days
since Onset Date.
Please update or
confirm.
Oct-21-2020 19:21:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 13:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 13:13:34
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973928
Page 143 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
Oct-26-2020 13:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
Oct-22-2020 11:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please complete this
field.
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-21-2020 19:21:42
(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-21-2020 19:21:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 13:35:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 13:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-26-2020 13:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
Oct-22-2020 11:03:21
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please complete this
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973929
Page 144 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) field.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-21-2020 19:21:42
(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-21-2020 19:21:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-21-2020 19:21:42
(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
Nov-30-2020 14:11:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-30-2020 14:11:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-30-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE headache:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-21-2020 19:21:42
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973930
Page 145 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) LVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020 19:21:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973931
Page 146 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 08:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-16-2020 08:45:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered This is a new
diagnosis of genital
herpes. It is recorded
appropriately as an
AE and not medical
history.
Nov-14-2020 05:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed closed based on
site's response
Nov-13-2020 18:41:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: pls advise if
subject with prior hx
genital HSV, if so
pls update MedHx
CRF accordingly.
Nov-13-2020 15:49:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The subject was
diagnosed more than
48 hours prior to the
vaccination and the
symptoms had
started even earlier
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0973932
Page 147 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
than the diagnosis.
No delay was
required.
Nov-13-2020 14:28:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Please
confirm if AE
"genital herpes" met
temporary delay
criteria. Thank you
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
genital herpesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-03-2021 12:19:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-02-2021 17:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered genital herpes
outbreaks can
resolve. however, the
condition cannot be
cured. there will be
no end date.
Feb-02-2021 16:49:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine if
this AE is still
Ongoing as it has
been 85 Days since
Onset Date.
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0973933
Page 148 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Nov-13-2020 11:09:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 09:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Nov-13-2020 09:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
Nov-13-2020 09:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please complete this
field.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-12-2020 14:10:15
(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
Nov-12-2020 14:10:15
(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
Nov-13-2020 11:10:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 09:37:11
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973934
Page 149 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
Nov-13-2020 09:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
genital sexually transmitted
disease not related to IPInitial Entry
Nov-13-2020 09:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please complete this
field.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020 14:10:15
(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
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973935
Page 150 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-12-2020 14:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973936
Page 151 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Jan-04-2021
09:27:19
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Clo
sedDiscrepancy has been
closed.
Jan-04-2021
08:13:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: An
swere
dTranscription Error
Jan-04-2021
08:13:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
infecti
on of
coxsa
ckievi
rusTranscription Error
Jan-04-2021
06:28:17
(UTC-06:00)
Central TimeACV0PFEINFP6000  Saumitra Dubey TMS
QueryQuery
2: Rei
ssued:
OpeneCoding Query:
Thanks for the
response. Coding of
the term cannot
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0973937
Page 152 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US &
Canada)dhappen as such. If this
is infection of
COXSACKIEVIRUS
then kindly update the
term to Infection of
COXSACKIEVIRUS.
Else clarify.
Dec-18-2020
11:27:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Svitlana Tonkovyd Query
1: Clo
sedResponse satisfies
query
Dec-18-2020
08:29:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dCoxsackievirus is the
medical condition
Dec-17-2020
18:24:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Op
enedClarify
COXSACKIEVIRUS
as follows...Are you
reporting TEST?
TEST POSITIVE?
INFECTION? Other?
If so, edit. Otherwise
clarify. Thank you.
Dec-17-2020
15:14:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: An
swere
dTranscription Error
Dec-17-2020
15:14:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
coxsa
ckievi
rusTranscription Error
Dec-17-2020
13:41:58
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Svitlana Tonkovyd Query
1: Op
enedGPD Clin: Please
consider replacing
"hand, foot, and
mouth disease" with a
more specific term, if
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0973938
Page 153 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada) known, Thanks
Dec-15-2020
15:14:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
hand,
foot, a
nd mo
uth di
seaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-15-2021 11:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/15/2020 11:58New Information
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973939
Page 154 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-15-2020 15:14:59
(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
Dec-15-2020 15:14:59
(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
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
other viral infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973940
Page 155 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-15-2021 12:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Jan-15-2021 11:58:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE infection of
coxsackievirus:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-15-2020 15:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973941
Page 156 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021 12:18:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Feb-25-2021 10:38:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered The form has been
updated and per
sponsor directives,
we are waiting for
the PI to return to
the site next week to
sign so it may be
submitted.
Feb-24-2021 16:22:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened Clinical Event term
for the pregnancy is
EDP; however, the
PG Safety report has
not been updated
(please complete this
section).
Feb-24-2021 16:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed term updated to EDP
Feb-17-2021 01:42:47
(UTC-06:00) CentralACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973942
Page 157 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
Feb-09-2021 08:29:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered The form has been
submitted. The
father's information
has not yet been
provided by the
subject.
Feb-08-2021 23:19:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical Event term
is Exposure during
Pregnancy; however,
PG report event term
is 'Pregnancy'.
Please submit a PG
safety followup to
report the revised
EDP event term.
Feb-08-2021 23:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical Please
submit EDP
supplemental form,
with subject OB
history, Father info
(age, meds,
exposures, social
history) and
contraception
information
Feb-08-2021 04:49:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Feb-04-2021 11:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-04-2021 11:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-04-2021 11:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
exposure during pregnancyTranscription Error
Feb-03-2021 22:47:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical Please
submit EDP
supplemental form,
with subject OB
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973943
Page 158 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
history, Father info
(age, meds,
exposures, social
history) and
contraception
information
Feb-03-2021 12:28:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Please
refer to eCRF
completion guide,
section 8.50.2.5 and
adjust the verbatim
accordingly and
confirm Exposure
During Pregnancy
has been reported to
Pfizer DSU. Thanks
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/19/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021 23:13:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed items 6 and 9 are
reported
Feb-08-2021 23:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973944
Page 159 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-08-2021 11:33:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered exposure during
pregnancy is not
applicable.sm
Feb-04-2021 12:01:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per
query
Feb-04-2021 12:01:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-03-2021 22:44:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Feb-03-2021 06:44:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for Data item#6 and
9 are missing.
Kindly review and
update.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-15-2021 22:07:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-11-2021 03:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Deleted Close Auto Query
Feb-09-2021 08:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate For AE exposure
during pregnancy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973945
Page 160 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Event Number" is
present.
Feb-09-2021 08:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered updated per query
Feb-09-2021 08:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOupdated per query
Feb-08-2021 23:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical As per CRF
CG 8.50.2.5, an
“Exposure During
Pregnancy” is not an
SAE [despite using
similar forms to
report pregnancy];
only abnormal
outcomes of
pregnancy are
evaluated for serious
criteria
Feb-05-2021 08:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 11:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE exposure
during pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-02-2021 10:31:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-02-2021 10:31:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in dTranscription Error
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973946
Page 161 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
YES
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria
is missing. Please
review and update as
appropriate.
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Other medically important serio
us event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973947
Page 162 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-02-2021 10:30:38
(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
Feb-08-2021 11:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
IntercourseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-02-2021 10:30:38
(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
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973948
Page 163 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-09-2021 16:43:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-09-2021 09:10:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered CRF guidelines
state to mark
outcome as
unknown. The
subject is still
pregnant so it has
been marked as
ongoing.
Feb-09-2021 09:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Feb-09-2021 09:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNupdated after review
of CRF guidelines
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-02-2021 10:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973949
Page 164 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-11-2021 03:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: downgraded to non
serious
Feb-05-2021 08:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
11011115Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973950
Page 165 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021 07:27:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-05-2021 09:02:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered an updated form was
sent yesterday
Mar-03-2021 14:48:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical - Followup;
the most recent PG
safety report update
(03Mar21) did not
include the
Coxsackie viral
infection prior Med
hx
Mar-02-2021 23:29:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Query closed; will
follow for requested
prior Coxsackie
infection
information.
Mar-02-2021 16:49:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered the medical condition
has been added to the
form and will be
submitted after the PI
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0973951
Page 166 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
signs tomorrow.
Mar-02-2021 12:24:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Please
submit the recent
Coxsackie virus
infection Dec 06-15,
2020 to the SAE
(#2021107155)
medical history
section
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spontaneous abortionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/20/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 12:19:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-25-2021 10:29:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The form has been
updated and per
sponsor directions,
we are waiting for
the PI to return to the
office to sign the
update so it can be
submitted.
Feb-25-2021 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical End date is
20Feb21; however,
SAE report
(2021107155) does
not report an end
date. Please submit
an update reporting
end date in Event
section under "STOP
date"
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0973952
Page 167 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/20/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-24-2021 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 11:15:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-24-2021 11:15:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
Feb-24-2021 06:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Toxicity
Grade" is missing.
Kindly review and
update.
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
Mar-09-2021 07:40:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Mar-08-2021 17:01:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered life-threatening has
never been selected
for this event. there is
nothing to update per
this query since it
was never selected.
Mar-08-2021 14:38:49 ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical - Thank you;
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973953
Page 168 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00) Central
Time (US & Canada)please submit a PG
Safety report to
remove
Life-threatening from
serious criteria in that
report as well.
Mar-08-2021 14:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered updated per query
Mar-08-2021 14:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
YESupdated per query
Mar-05-2021 21:46:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical - if there is
no specific
Congenital
Abnormality or Birth
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973954
Page 169 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Defect, please select
another serious
criterion; also,
Update PG safety
report with the new
serious criterion
Mar-03-2021 16:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered The subject
miscarried. If you
would like this
updated to something
else, like important
medical event, the
site will do so.
Mar-03-2021 14:46:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical Thank you;
please specify what
'Congenital
Abnormality or Birth
Defect' was
observed; submit as a
SAE safety update
Feb-25-2021 10:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered important medical
event was submitted
as the reason for SAE
form for the exposure
during pregnancy on
that paper
submission.
congenital anomaly
or birth defect was
selected for the SAE
of spontaneous
abortion on the form
submitted for that
SAE
Feb-25-2021 09:59:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical Please
clarify if miscarriage
was not only Med
Important (as
reported SAE
#2021107155), but
also associated with a
congenital
abnormality / birth
defect, as reported by
serious criteria
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0973955
Page 170 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
selection on AE log
CRF. Please add Med
Important on AE
CRF
Feb-25-2021 09:57:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed rewording
Feb-24-2021 16:25:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical Please
submit a Safety
update
(#2021107155) to
enter the event
Spontaneous Ab.
Please clarify if
miscarriage was not
only Med Important,
but also associated
with a congenital
abnormality / birth
defect, as reported by
serious criteria
selection
Feb-24-2021 05:17:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE spontaneous
abortion: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
YES
Did this serious event result in
death?
NOInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973956
Page 171 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-23-2021 17:01:45
(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
Mar-01-2021 10:49:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-26-2021 09:41:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Feb-26-2021 09:41:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERNew Information
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973957
Page 172 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
If Other, specify:
unknown, but subject has a
history or pregnancy comp
lications
Feb-26-2021 09:15:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINREQUERY:
This Specific Reason
entered is not relevant
to the CAUSALITY
of this AE. Does Site
know the Causality of
the Spontaneous
Abortion? If not,
please determine if
UNKNOWN should
be entered.
Feb-26-2021 09:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-25-2021 10:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-25-2021 10:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
NA:unblinded for transitio
n before pregnancy discov
ered. placebo was receivedTranscription Error
Feb-25-2021 09:42:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY: Per
CRF Guidelines, if
OTHER is Selected,
please enter the
Causality of the AE
in the SPECIFY field.
Please update
accordingly as this
data is only partially
entered.
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0973958
Page 173 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-24-2021 15:40:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 11:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-24-2021 11:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
Feb-24-2021 06:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response for
"Is this event related
to study treatment" is
missing. Kindly
review and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-01-2021 02:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-26-2021 09:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered updated per
directions given in
query
Feb-26-2021 09:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOupdated per
directions given in
query
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973959
Page 174 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 09:27:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-26-2021 00:17:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM Requery: As
per response, please
provide the data as
No. Thank you.
Feb-25-2021 10:27:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The subject was not
able to provide the
information and we
do not have any
documents
providing the
information. The
site does not know
the answer.
Feb-25-2021 07:10:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Per site comment
"comment added
and question marked
unknown", however
unknown is not a
valid response.
Please review and
update. Else clarify.
Feb-24-2021 11:12:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered comment added and
question marked
unknown
Feb-24-2021 11:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
Feb-24-2021 06:20:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Was a
Concomitant
Medication given?"
is missing. Kindly
review and update.
12. Was a Non-Drug Treatment given?
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973960
Page 175 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Feb-28-2021 22:30:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-26-2021 09:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Updated per
directions given by
DM in the conmed
treatment question.
The subject did not
provide the
information.
Feb-26-2021 09:43:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOUpdated per
directions given by
DM in the conmed
treatment question.
The subject did not
provide the
information.
Feb-26-2021 09:42:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-26-2021 09:32:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM 2 : Thank you
for response. Please
verify the data in
source documents.
Discuss with
CRA/investigator if
required and consider
to update the missing
data once contact
made with patient.
Feb-25-2021 10:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The subject was not
able to provide the
information and we
do not have any
documents providing
the information. The
site does not know
the answer.
Feb-25-2021 07:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Per site comment
"comment added and
marked unknown",
however unknown is
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973961
Page 176 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
not a valid response.
Please review and
update. Else clarify.
Feb-24-2021 11:13:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered comment added and
marked unknown
Feb-24-2021 11:12:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
Feb-24-2021 06:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Was a Non-Drug
Treatment given?" is
missing. Kindly
review and update.
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021 17:01:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-04-2021 00:50:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2021107155Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973962
Page 177 of 181
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-10-2020 14:34:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-10-2020 14:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-10-2020 14:34:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973963
Page 178 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021 17:04:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973964
Page 179 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-02-2021 17:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-02-2021 17:04:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-02-2021 17:04:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per other protocol allo
wance(s) and confirmed to ha
ve received only placebo at Va
ccination 1/2Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973965
Page 180 of 181
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-02-2021 17:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-02-2021 17:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0973966
Page 181 of 181
***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: 1101 Site Name: (1101) Prairie Fields Family Medicine
Subject No: 11011115 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-10-2020 14:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-20-2020 17:20:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-20-2020 16:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-10-2020 14:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-20-2020 17:20:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Oct-20-2020 16:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
090177e196ae306a\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973967