Document text
Page 1 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941025
Page 2 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/27/2020
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941026
Page 3 of 205
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411270]
2.Birth Date: /1999
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:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941027
Page 4 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941028
Page 5 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941029
Page 6 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941030
Page 7 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized Anxiety Disorder]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Klippel Feil Deformity]
Start Date: /1999
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Augmentin]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941031
Page 8 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[R Foot Lisfranc Fracture Repair]
Start Date: Oct/11/2013
Ongoing: NO
End Date:
Oct/11/2013
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L Knee Medial Meniscus Repair]
Start Date: Nov/28/2016
Ongoing: NO
End Date:
Nov/28/2016
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L Knee Medial Meniscus Tear]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
Nov/28/2016
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[R Foot Lisfranc Fracture]
Start Date: Oct/UNK/2013
Ongoing: NO
End Date:
Oct/11/2013
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941032
Page 9 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Wisdom Teeth Removal]
Start Date: May/UNK/2020
Ongoing: NO
End Date:
May/UNK/2020
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941033
Page 10 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941034
Page 11 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [88.6]
3.Unit: kg
4.Height: [178.0]
5.Unit: cm
6.Body Mass Index: [28.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941035
Page 12 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/27/2020
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:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941036
Page 13 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [111532]
3.Randomization Group: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941037
Page 14 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP9MBR]
5.bSample ID [BRX74K]
5.cSample ID [BRX74J]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941038
Page 15 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP9MBP]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941039
Page 16 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/27/2020 14:28
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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941040
Page 17 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941041
Page 18 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941042
Page 19 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941043
Page 20 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941044
Page 21 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9LR2]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941045
Page 22 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/17/2020 14:30
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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941046
Page 23 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941047
Page 24 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
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 [BLFYZD]
5.bSample ID [BLFYZC]
5.cSample ID [BP9LS8]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941048
Page 25 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941049
Page 26 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941050
Page 27 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941051
Page 28 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941052
Page 29 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941053
Page 30 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941054
Page 31 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941055
Page 32 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941056
Page 33 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941057
Page 34 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941058
Page 35 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 injection site pain Dec/23/2020
15:00 NO
End Date Time:
Dec/25/2020 08:30
Repeating
Pages
2.ADVERSE E
VENT 2 injection site soreness left d
eltoid Jan/13/2021 1
4:00 NO
End Date Time:
Jan/14/2021 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 muscles aches Jan/14/2021 0
1:00 NO
End Date Time:
Jan/14/2021 09:00
Repeating
Pages
4.ADVERSE E
VENT 4 Fatigue Jan/14/2021 0
1:00 NO
End Date Time:
Jan/14/2021 09:00
Repeating
Pages
5.ADVERSE E
VENT 5 chills Jan/14/2021 0
1:00 NO
End Date Time:
Jan/14/2021 09:00
Repeating
Pages
6.ADVERSE E
VENT 6 elevated body temperature t
max 100.0F Jan/14/2021 0
1:00 NO
End Date Time:
Jan/14/2021 09:00
Repeating
Pages
7.ADVERSE E
VENT 7 malaise Jan/14/2021 0
1:00 NO
End Date Time:
Jan/14/2021 09:00
Repeating
Pages
8.ADVERSE E
VENT 8 enlarged lymph node left ar
m axillary Jan/15/2021 0
8:00 NO
End Date Time:Repeating
Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941059
Page 36 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
Jan/17/2021 UNK:UN
K
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941060
Page 37 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Dec/23/2020 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/25/2020 08:30
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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941061
Page 38 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941062
Page 39 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site soreness left deltoid]
4.Start Date Time: Jan/13/2021 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941063
Page 40 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941064
Page 41 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[muscles aches]
4.Start Date Time: Jan/14/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941065
Page 42 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941066
Page 43 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Jan/14/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 09:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941067
Page 44 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941068
Page 45 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Jan/14/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941069
Page 46 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941070
Page 47 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[elevated body temperature tmax 100.0F]
4.Start Date Time: Jan/14/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 09:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941071
Page 48 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941072
Page 49 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[malaise]
4.Start Date Time: Jan/14/2021 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941073
Page 50 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941074
Page 51 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[enlarged lymph node left arm axillary]
4.Start Date Time: Jan/15/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/17/2021 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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941075
Page 52 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941076
Page 53 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941077
Page 54 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941078
Page 55 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941079
Page 56 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941080
Page 57 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941081
Page 58 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941082
Page 59 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941083
Page 60 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941084
Page 61 of 205
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941085
Page 62 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941086
Page 63 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941087
Page 64 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941088
Page 65 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941089
Page 66 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941090
Page 67 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941091
Page 68 of 205
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941092
Page 69 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941093
Page 70 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941094
Page 71 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941095
Page 72 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941096
Page 73 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941097
Page 74 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941098
Page 75 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941099
Page 76 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/23/2020
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941100
Page 77 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941101
Page 78 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/23/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941102
Page 79 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/23/2020
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:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941103
Page 80 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
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 [BLFZ2C]
5.bSample ID [BLFZ2D]
5.cSample ID [BP9LVZ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941104
Page 81 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
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 [BP9LW0]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941105
Page 82 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/23/2020 10:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941106
Page 83 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941107
Page 84 of 205
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941108
Page 85 of 205
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941109
Page 86 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941110
Page 87 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/13/2021
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:
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941111
Page 88 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9LYY]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941112
Page 89 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 09:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941113
Page 90 of 205
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941114
Page 91 of 205
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/15/2021
3.Comments: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941115
Page 92 of 205
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941116
Page 93 of 205
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941117
Page 94 of 205
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941118
Page 95 of 205
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941119
Page 96 of 205
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/15/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941120
Page 97 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/15/2020
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941121
Page 98 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941122
Page 99 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia
Winokur Approved Feb-24-2021 08:26:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941123
Page 100 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-27-2020 18:21:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941124
Page 101 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormDec-23-2020 13:14:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941125
Page 102 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia
Winokur Approved Feb-24-2021 08:26:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-19-2021 12:56:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-18-2021 13:28:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-15-2021 09:54:54 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941126
Page 103 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Patricia
Winokur Approved Feb-12-2021 13:39:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-10-2021 10:48:00 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Jan-22-2021 17:45:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-16-2021 13:49:01 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Jan-14-2021 16:56:55 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941127
Page 104 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-13-2021 15:18:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Jan-04-2021 11:37:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-28-2020 11:51:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-28-2020 08:41:48 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941128
Page 105 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-23-2020 13:12:26 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-17-2020 10:38:01 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-15-2020 14:23:50 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-07-2020 14:39:32 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941129
Page 106 of 205
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-17-2020 17:11:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-10-2020 16:33:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941130
Page 107 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-27-2020 18:21:15
(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-27-2020 18:21:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941131
Page 108 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-27-2020 18:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/27/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941132
Page 109 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-27-2020 18:21:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11411270Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-27-2020 18:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1999Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-27-2020 18:21:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-27-2020 18:21:30
(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-27-2020 18:21:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941133
Page 110 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020 18:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941134
Page 111 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-27-2020 18:21:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 18:21:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 18:21:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941135
Page 112 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Oct-27-2020 18:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Generalized Anxi
ety Disorder
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:22:16
(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-27-2020 18:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Generalized Anxiety DisorderInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-27-2020 18:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-27-2020 18:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941136
Page 113 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b
Date Location User Value Reason
Oct-27-2020 18:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Seasonal Aller
gies
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:22:29
(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-27-2020 18:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-27-2020 18:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-27-2020 18:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941137
Page 114 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-27-2020 18:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Klippel Feil Def
ormity
Start Date: /1999
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:22:46
(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-27-2020 18:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Klippel Feil DeformityInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-27-2020 18:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-27-2020 18:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-27-2020 18:23:13 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941138
Page 115 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Numb
er:4
Medical History
Term:Allergy to Aug
mentin
Start Date: UNK/UNK/200
1
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:23:13
(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-27-2020 18:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to AugmentinInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-27-2020 18:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-27-2020 18:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-27-2020 18:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941139
Page 116 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medical Hist
ory Term:R Foot Lisfranc Fr
acture Repair
Start Date: Oct/11/2013
Ongoing: NO
End Date:
Oct/11/2013
1.e Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:23:42
(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-27-2020 18:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
R Foot Lisfranc Fracture RepairInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-27-2020 18:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/11/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-27-2020 18:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/11/2013Initial Entry
1.f
Date Location User Value Reason
Oct-27-2020 18:24:07 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941140
Page 117 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Nu
mber:6
Medical Hist
ory Term:L Knee Medial Me
niscus Repair
Start Date: Nov/28/2016
Ongoing: NO
End Date:
Nov/28/2016
1.f Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:24:07
(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-27-2020 18:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
L Knee Medial Meniscus RepairInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-27-2020 18:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-27-2020 18:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/28/2016Initial Entry
1.g
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941141
Page 118 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-27-2020 18:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:L Knee Medial Me
niscus Tear
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
Nov/28/2016Initial Entry
1.g Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 18:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
L Knee Medial Meniscus TearInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-27-2020 18:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-27-2020 18:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/28/2016Initial Entry
1.h
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941142
Page 119 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-27-2020 18:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:R Foot Lisfranc
Fracture
Start Date: Oct/UNK/2013
Ongoing: NO
End Date:
Oct/11/2013Initial Entry
1.h Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 18:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
R Foot Lisfranc FractureInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-27-2020 18:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/UNK/2013Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-27-2020 18:25:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/11/2013Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941143
Page 120 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i
Date Location User Value Reason
Oct-27-2020 18:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:Wisdom Teeth R
emoval
Start Date: May/UNK/2020
Ongoing: NO
End Date:
May/UNK/20
20Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941144
Page 121 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Oct-27-2020 18:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 18:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Wisdom Teeth RemovalInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-27-2020 18:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-27-2020 18:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/UNK/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941145
Page 122 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-27-2020 18:25:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941146
Page 123 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
88.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
178.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.0Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941147
Page 124 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 99.0
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-27-2020 18:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941148
Page 125 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-27-2020 18:26:06
(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-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-27-2020 18:26:06
(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-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941149
Page 126 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-27-2020 18:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941150
Page 127 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-27-2020 18:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-27-2020 18:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
111532Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941151
Page 128 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 18:26:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 18:26:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 06:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-28-2020 05:41:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 18:26:19
(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-27-2020 18:26:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941152
Page 129 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Oct-28-2020 06:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9MBRInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 06:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9MBRInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 06:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX74KInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 06:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRX74KInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 06:23:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX74JInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 06:23:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRX74JInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941153
Page 130 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 18:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 18:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 06:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-28-2020 05:41:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 18:26:24
(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-27-2020 18:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941154
Page 131 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Oct-28-2020 06:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9MBPInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 06:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9MBPInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941155
Page 132 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-27-2020 18:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020 18:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020 18:26:38
(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-27-2020 18:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 14:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020 18:26:38
(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-27-2020 18:26:38
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941156
Page 133 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-27-2020 18:26:38
(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-27-2020 18:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-27-2020 18:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941157
Page 134 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-27-2020 18:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941158
Page 135 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 17:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941159
Page 136 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2.a
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (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-2021-5683-0941160
Page 137 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a Temperature Location:
Date Location User Value Reason
Nov-17-2020 17:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941161
Page 138 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-17-2020 17:12:05
(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-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-17-2020 17:12:05
(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-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941162
Page 139 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-17-2020 17:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941163
Page 140 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 17:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 17:12:13
(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-18-2020 05:51:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-18-2020 04:01:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-17-2020 17:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-17-2020 17:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941164
Page 141 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Nov-18-2020 05:51:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LR2Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-18-2020 05:51:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9LR2Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941165
Page 142 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-17-2020 17:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-17-2020 17:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-17-2020 17:12:30
(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-17-2020 17:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020 14:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-17-2020 17:12:30
(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-17-2020 17:12:30
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941166
Page 143 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-17-2020 17:12:30
(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-17-2020 17:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-17-2020 17:12:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941167
Page 144 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 23:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-16-2020 14:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-16-2020 03:46:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The treatment
period is defined as
1st vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF
and update date of
EOT to match date
of visit at visit 3.
Dec-15-2020 14:23:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941168
Page 145 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-15-2020 14:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020 14:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 06:05:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-16-2020 05:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-15-2020 14:24:41
(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-15-2020 14:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941169
Page 146 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Dec-17-2020 06:05:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFYZDInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 06:05:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFYZDInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020 06:05:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFYZCInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 06:05:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFYZCInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 06:05:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LS8Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 06:05:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9LS8Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941170
Page 147 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941171
Page 148 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941172
Page 149 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941173
Page 150 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941174
Page 151 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941175
Page 152 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941176
Page 153 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941177
Page 154 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941178
Page 155 of 205
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 15:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/25/2020 08:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941179
Page 156 of 205
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-19-2021 23:18:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-19-2021 10:00:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Jan-14-2021 22:57:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete item # 9,
11 and 12. Thank
you.
Jan-13-2021 15:21:38
(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
Jan-16-2021 13:49:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (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), (b)
(6)
FDA-CBER-2021-5683-0941180
Page 157 of 205
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-19-2021 09:57:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021 09:57:03
(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
Jan-13-2021 15:21:38
(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
Jan-13-2021 15:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941181
Page 158 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:33:19
(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-16-2021 10:33:19
(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
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site soreness left deltoidInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941182
Page 159 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 10:33:19
(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
Feb-16-2021 10:33:19
(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-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941183
Page 160 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:33:19
(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
Feb-16-2021 10:33:19
(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-16-2021 10:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941184
Page 161 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:34:51
(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-16-2021 10:34:51
(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
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
muscles achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941185
Page 162 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:34:51
(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
Feb-16-2021 10:34:51
(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
Feb-16-2021 10:34:51
(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-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941186
Page 163 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:34:51
(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
Feb-16-2021 10:34:51
(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-16-2021 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941187
Page 164 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941188
Page 165 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941189
Page 166 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-16-2021 10:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941190
Page 167 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:37:39
(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-16-2021 10:37:39
(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
Feb-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941191
Page 168 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:37:39
(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
Feb-16-2021 10:37:39
(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
Feb-16-2021 10:37:39
(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-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941192
Page 169 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:37:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:37:52
(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
Feb-16-2021 10:37:39
(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-16-2021 10:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941193
Page 170 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:38:54
(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-16-2021 10:38:54
(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
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperature tmax
100.0FInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941194
Page 171 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 10:38:54
(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
Feb-16-2021 10:38:54
(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-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941195
Page 172 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:38:54
(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
Feb-16-2021 10:38:54
(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-16-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941196
Page 173 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
malaiseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941197
Page 174 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:40:04
(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
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941198
Page 175 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 10:40:04
(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-16-2021 10:40:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941199
Page 176 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:44:41
(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-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
enlarged lymph node left arm axi
llaryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/17/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941200
Page 177 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 10:44:41
(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
Feb-16-2021 10:44:41
(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-22-2021 05:17:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed data updated.
Feb-19-2021 12:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-19-2021 12:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDNew Information
Feb-16-2021 23:42:54
(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
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941201
Page 178 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
review and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 10:44:41
(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-16-2021 10:44:41
(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-16-2021 10:44:41
(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
Feb-16-2021 10:44:41
(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-16-2021 10:44:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0941202
Page 179 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-16-2020 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941203
Page 180 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941204
Page 181 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-23-2020 13:13:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941205
Page 182 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020 13:13:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941206
Page 183 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-23-2020 13:13:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/23/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941207
Page 184 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-11-2021 01:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Feb-10-2021 10:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-10-2021 10:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Transcription Error
Feb-09-2021 08:59:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu
R Query 1: Opened Date of
Completion/Discontinuation
/Death is reported as
18Dec2020, however
subject consented for
revaccination on
23Dec2020. Please review
and update this date as
appropriate. Else clarify.
Dec-23-2020 13:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-23-2020 13:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-23-2020 13:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941208
Page 185 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941209
Page 186 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-23-2020 13:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941210
Page 187 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 13:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 13:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 11:51:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-24-2020 05:54:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 13:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 13:15:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941211
Page 188 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Dec-28-2020 11:51:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFZ2CInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 11:51:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFZ2CInitial Entry
5.b
Date Location User Value Reason
Dec-28-2020 11:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFZ2DInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-28-2020 11:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFZ2DInitial Entry
5.c
Date Location User Value Reason
Dec-28-2020 11:51:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LVZInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-28-2020 11:51:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9LVZInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941212
Page 189 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 13:15:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 13:15:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 11:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-24-2020 05:54:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 13:15:55
(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-23-2020 13:15:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941213
Page 190 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Dec-28-2020 11:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LW0Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 11:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9LW0Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941214
Page 191 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 10:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941215
Page 192 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-23-2020 13:17:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941216
Page 193 of 205
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-23-2020 13:12:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-23-2020 13:12:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0941217
Page 194 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 15:18:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941218
Page 195 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941219
Page 196 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Jan-13-2021 15:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941220
Page 197 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411270 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 15:18:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 15:18:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 15:19:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 15:18:44
(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.
Jan-13-2021 15:18:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 15:19:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9LYYInitial Entry
090177e196ae4090\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941221
Page 198 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-
…[truncated]