Document text
Page 1 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940850
Page 2 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep/18/2020
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940851
Page 3 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411230]
2.Birth Date: /1974
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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940852
Page 4 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940853
Page 5 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940854
Page 6 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940855
Page 7 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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:[hyperhidrosis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraines]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right eye farsighted]
Start Date: UNK/UNK/1978
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left eye nearsighted]
Start Date: UNK/UNK/1978
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[amblyopia]
Start Date: UNK/UNK/1978
Ongoing: YES
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940856
Page 8 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gallbladder pain]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gallbladder removal]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroparesis]
Start Date: Jan/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to zoloft]
Start Date: UNK/UNK/2013
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940857
Page 9 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diethylstilbestrol grandchild]
Start Date: UNK/UNK/1974
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tipped cervix]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940858
Page 10 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940859
Page 11 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [56.2]
3.Unit: kg
4.Height: [160.5]
5.Unit: cm
6.Body Mass Index: [21.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940860
Page 12 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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: Sep/18/2020
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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940861
Page 13 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [92917]
3.Randomization Group: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940862
Page 14 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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:
Sep/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM6J0T]
5.bSample ID [BLC9JT]
5.cSample ID [BLC9JV]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940863
Page 15 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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:
Sep/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM6J0P]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940864
Page 16 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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: Sep/18/2020 09:20
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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940865
Page 17 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940866
Page 18 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940867
Page 19 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940868
Page 20 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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/16/2020
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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940869
Page 21 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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/16/2020
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 [BP9M8P]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940870
Page 22 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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/16/2020 15:37
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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940871
Page 23 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940872
Page 24 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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:
Nov/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9MFD]
5.bSample ID [BLFYWK]
5.cSample ID [BLFYWL]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940873
Page 25 of 175
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940874
Page 26 of 175
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940875
Page 27 of 175
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940876
Page 28 of 175
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940877
Page 29 of 175
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940878
Page 30 of 175
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940879
Page 31 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940880
Page 32 of 175
***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: 11411230 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: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940881
Page 33 of 175
***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: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940882
Page 34 of 175
***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: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940883
Page 35 of 175
***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: 11411230 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?
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940884
Page 36 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940885
Page 37 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940886
Page 38 of 175
***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: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940887
Page 39 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940888
Page 40 of 175
***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: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940889
Page 41 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940890
Page 42 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940891
Page 43 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 enlarged left interior neck lym
ph node Sep/30/2020 UN
K:UNK YES Repeating
Pages
2.ADVERSE E
VENT 2 injection site soreness left ar
m Sep/18/2020 13:
30 NO
End Date Time:
Sep/20/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE E
VENT 3 muscle aches Sep/18/2020 18:
00 NO
End Date Time:
Oct/1/2020 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 elevated body temperature, te
mperature 99.1 Sep/20/2020 UN
K:UNK NO
End Date Time:
Sep/20/2020 UNK:U
NK
Repeating
Pages
5.ADVERSE E
VENT 5 Myalgia in Entire Back Oct/17/2020 07:
00 NO
End Date Time:
Oct/19/2020 07:00
Repeating
Pages
6.ADVERSE E
VENT 6 Right Sided Upper Back Pain Oct/17/2020 10:
00 NO
End Date Time:
Oct/17/2020 11:00
Repeating
Pages
7.ADVERSE E
VENT 7 Injection Site Pain Oct/16/2020 16:
00 NO
End Date Time:
Oct/19/2020 07:00
Repeating
Pages
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940892
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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)[enlarged left interior neck lymph node]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940893
Page 45 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940894
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 arm]
4.Start Date Time: Sep/18/2020 13:30
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940895
Page 47 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940896
Page 48 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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)[muscle aches]
4.Start Date Time: Sep/18/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940897
Page 49 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940898
Page 50 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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)[elevated body temperature, temperature 99.1]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940899
Page 51 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940900
Page 52 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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)[Myalgia in Entire Back]
4.Start Date Time: Oct/17/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 07:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940901
Page 53 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940902
Page 54 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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)[Right Sided Upper Back Pain]
4.Start Date Time: Oct/17/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 11:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Physical Exertion]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940903
Page 55 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940904
Page 56 of 175
***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: 11411230 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)[Injection Site Pain]
4.Start Date Time: Oct/16/2020 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 07:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940905
Page 57 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940906
Page 58 of 175
***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: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940907
Page 59 of 175
***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: 11411230 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[ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940908
Page 60 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Influenza Vacci
ne Nov/5/20
20 Repeating
Pages
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940909
Page 61 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influenza Vaccine]
5.Date: Nov/5/2020
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940910
Page 62 of 175
***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: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940911
Page 63 of 175
***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: 11411230 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?
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940912
Page 64 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940913
Page 65 of 175
***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: 11411230 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?
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940914
Page 66 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940915
Page 67 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940916
Page 68 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940917
Page 69 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940918
Page 70 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940919
Page 71 of 175
***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: 11411230 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:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940920
Page 72 of 175
***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: 11411230 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?
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940921
Page 73 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940922
Page 74 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940923
Page 75 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940924
Page 76 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940925
Page 77 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940926
Page 78 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940927
Page 79 of 175
***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: 11411230 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: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940928
Page 80 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940929
Page 81 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940930
Page 82 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940931
Page 83 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940932
Page 84 of 175
***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: 11411230 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: [ ]
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940933
Page 85 of 175
***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: 11411230 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 Nov/13/2020
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940934
Page 86 of 175
***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: 11411230 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
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940935
Page 87 of 175
***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: 11411230 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-18-2021 13:22:07 (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.
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940936
Page 88 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 10:37:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940937
Page 89 of 175
***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: 11411230 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-18-2021 13:22:07 (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 06:49:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-01-2021 11:58:53 (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-28-2021 11:22:34 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-07-2020 14:49:18 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940938
Page 90 of 175
***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: 11411230 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-23-2020 09:34:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-16-2020 11:22:52 (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 Nov-13-2020 17:09:28 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-13-2020 17:06:51 (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.
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940939
Page 91 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
N/A Nov-13-2020 16:20:46 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-10-2020 16:06:32 (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.
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940940
Page 92 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep-18-2020 10:36:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-18-2020 10:36:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940941
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020 10:36:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/18/2020Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940942
Page 94 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020 10:36:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11411230Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020 10:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020 10:37:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-18-2020 10:37:18
(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
Sep-18-2020 10:37:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4093\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-2021-5683-0940943
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 10:37:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940944
Page 96 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep-18-2020 10:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 10:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 10:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940945
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020 10:38:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:hyperhidrosis
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:38:51
(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
Sep-18-2020 10:38:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hyperhidrosisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-18-2020 10:38:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-18-2020 10:38:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae4093\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-2021-5683-0940946
Page 98 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-18-2020 10:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:migraines
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 10:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
migrainesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020 10:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020 10:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-18-2020 10:39:16
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 3Initial Entry
090177e196ae4093\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-2021-5683-0940947
Page 99 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) r:
Medical History
Term:Right eye farsi
ghted
Start Date: UNK/UNK/19
78
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:39:16
(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
Sep-18-2020 10:39:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Right eye farsightedInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-18-2020 10:39:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1978Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-18-2020 10:39:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-18-2020 10:39:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:left eye nearsig
htedInitial Entry
090177e196ae4093\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-2021-5683-0940948
Page 100 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: UNK/UNK/19
78
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:39:28
(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
Sep-18-2020 10:39:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
left eye nearsightedInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-18-2020 10:39:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1978Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-18-2020 10:39:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-18-2020 10:39:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:amblyopia
Start Date: UNK/UNK/1
978
Ongoing: YESInitial Entry
090177e196ae4093\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-2021-5683-0940949
Page 101 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:39:54
(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
Sep-18-2020 10:39:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
amblyopiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-18-2020 10:39:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1978Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-18-2020 10:39:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-18-2020 10:40:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:gallbladder pain
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013Initial Entry
090177e196ae4093\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-2021-5683-0940950
Page 102 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:40:13
(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
Sep-18-2020 10:40:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gallbladder painInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-18-2020 10:40:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-18-2020 10:40:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.g
Date Location User Value Reason
Sep-18-2020 10:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:gallbladder rem
oval
Start Date: UNK/UNK/201
3Initial Entry
090177e196ae4093\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-2021-5683-0940951
Page 103 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
UNK/UNK/
2013
1.g Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:40:31
(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
Sep-18-2020 10:40:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gallbladder removalInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-18-2020 10:40:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-18-2020 10:40:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.h
Date Location User Value Reason
Sep-18-2020 10:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:gastroparesisInitial Entry
090177e196ae4093\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-2021-5683-0940952
Page 104 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: Jan/UNK/20
16
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:41:02
(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
Sep-18-2020 10:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gastroparesisInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-18-2020 10:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-18-2020 10:41:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-18-2020 10:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:allergy to zolo
ft
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
090177e196ae4093\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-2021-5683-0940953
Page 105 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:41:24
(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
Sep-18-2020 10:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
allergy to zoloftInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-18-2020 10:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-18-2020 10:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-18-2020 10:41:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:depression
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
090177e196ae4093\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-2021-5683-0940954
Page 106 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:41:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 10:41:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-18-2020 10:41:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-18-2020 10:41:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4093\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-2021-5683-0940955
Page 107 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.k
Date Location User Value Reason
Sep-18-2020 12:58:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:diethylstilbestrol
grandchild
Start Date: UNK/UNK/1974
Ongoing: YESNew Information
Sep-18-2020 10:42:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:diethyl
Start Date: UNK/UNK/1
974
Ongoing: YESInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0940956
Page 108 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:42:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-18-2020
14:36:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been closed.
Sep-18-2020
12:58:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew Information
Sep-18-2020
12:58:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
diethy
lstilbe
strol g
randc
hildNew Information
Sep-18-2020
12:28:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify DIETHYL as
follows...Drug only reported
and appears incomplete. Are
you reporting ALLERGY TO
DIETHYLCARBAMAZINE?
INTERACTION WITH
DIETHYLCARBAMAZINE?
Other? Please update the
verbatim term to clarify. If
reporting therapeutic use,
please move the term to the
drug page. Thank you.
Sep-18-2020 ACV0PFEINFP6000 DataInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940957
Page 109 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10:42:48
(UTC-06:00)
Central Time
(US &
Canada)Entry
:
diethy
l
1.k Start Date:
Date Location User Value Reason
Sep-18-2020 10:42:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1974Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-18-2020 10:42:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-18-2020 10:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History T
erm:tipped cervix
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940958
Page 110 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.l Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 10:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tipped cervixInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-18-2020 10:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-18-2020 10:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4093\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-2021-5683-0940959
Page 111 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep-18-2020 10:44:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940960
Page 112 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
56.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
160.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21.8Initial Entry
090177e196ae4093\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-2021-5683-0940961
Page 113 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.7
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 10:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4093\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-2021-5683-0940962
Page 114 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin 113Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940963
Page 115 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) ed Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 10:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940964
Page 116 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020 10:45:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020 10:45:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
92917Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940965
Page 117 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 10:45:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 10:45:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 12:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 10:45:26
(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.
Sep-18-2020 10:45:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 12:08:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM6J0TInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940966
Page 118 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 12:08:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM6J0TInitial Entry
5.b
Date Location User Value Reason
Sep-18-2020 12:08:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLC9JTInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020 12:08:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLC9JTInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020 12:08:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLC9JVInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020 12:08:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLC9JVInitial Entry
090177e196ae4093\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-2021-5683-0940967
Page 119 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 10:45:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 10:45:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 06:16:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-20-2020 01:11:16
(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.
Sep-18-2020 10:45:32
(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.
Sep-18-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940968
Page 120 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-21-2020 06:16:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM6J0PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 06:16:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM6J0PInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940969
Page 121 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 09:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4093\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-2021-5683-0940970
Page 122 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Sep-18-2020 10:45:46
(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
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 10:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940971
Page 123 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Sep-18-2020 10:45:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940972
Page 124 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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-26-2020
00:13:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edAs per site
confirmation -
updated PD tracker
Oct-25-2020
10:50:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredentered as correct,
subject rescheduled
due to follow up
Oct-19-2020
02:54:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Open
edPDQ: Date of visit at
V2_VAX2_L is out
of window for 5
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Oct-16-2020
16:36:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/16/
2020Initial Entry
090177e196ae4093\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) (4)
(b) (4)
FDA-CBER-2021-5683-0940973
Page 125 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 99.0
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae4093\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-2021-5683-0940974
Page 126 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 16:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940975
Page 127 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020 16:38:13
(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-16-2020 16:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020 16:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020 16:38:13
(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-16-2020 16:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-16-2020 16:38:13
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin 113Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940976
Page 128 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) ed Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020 16:38:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-16-2020 16:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-16-2020 16:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940977
Page 129 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 16:13:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 16:13:23
(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-16-2020 16:13:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 16:13:23
(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-16-2020 16:13:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 16:13:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9M8PInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940978
Page 130 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 16:13:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9M8PInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940979
Page 131 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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-16-2020 16:39:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 16:39:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 16:39:59
(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-16-2020 16:39:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 15:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 16:39:59
(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-16-2020 16:39:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4093\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-2021-5683-0940980
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Oct-16-2020 16:39:59
(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-16-2020 16:39:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-16-2020 16:39:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940981
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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-13-2020 17:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940982
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:20:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:20:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 16:20:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:20:46
(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-13-2020 16:20:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 16:20:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9MFDInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940983
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 16:20:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9MFDInitial Entry
5.b
Date Location User Value Reason
Nov-13-2020 16:21:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFYWKInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 16:21:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFYWKInitial Entry
5.c
Date Location User Value Reason
Nov-13-2020 16:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFYWLInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-13-2020 16:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLFYWLInitial Entry
090177e196ae4093\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-2021-5683-0940984
Page 136 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940985
Page 137 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940986
Page 138 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940987
Page 139 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940988
Page 140 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940989
Page 141 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940990
Page 142 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940991
Page 143 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020
21:01:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 2: Close
dResponse
satisfies query
Oct-29-2020
16:08:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answ
eredNew Information
Oct-29-2020
16:08:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
enlarged left in
terior neck lym
ph nodeNew Information
Oct-26-2020
17:35:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 2: Open
edGPDCLIN:
Please document
if enlarged
interior neck
lymph node is
right, left or
bilateral. Thank
you
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940992
Page 144 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-25-2020
11:18:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Oct-25-2020
10:53:23
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredNew Information
Oct-25-2020
10:53:23
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
enlarged interi
or neck lymph
nodeNew Information
Oct-17-2020
00:59:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Open
edClarify
ENLARGED
INTERIOR
NECK NODE as
follows...Clarify
NODE. Are you
reporting SKIN
NODULE? Or
LYMPH NODE?
Or other? Please
update the
verbatim term to
clarify. Thank
you.
Oct-16-2020
16:57:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
enlarged interi
or neck nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940993
Page 145 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Dec-18-2020 08:20:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 2: Closed Response satisfies
query
Dec-15-2020 07:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered yes this is still
ongoing
Dec-14-2020 05:40:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 2: Opened Clin: Please
confirm if this AE
is still ongoing
Nov-09-2020 11:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Closed Response satisfies
query
Nov-09-2020 10:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject states that it
is still ongoing.
Nov-09-2020 09:47:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Opened Clin: Please
confirm if this AE
is still ongoing
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 05:55:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-25-2020 10:52:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-25-2020 10:52:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1New Information
Oct-19-2020 05:14:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for Data item#6,8,9
are missing. Kindly
review and update.
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0940994
Page 146 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 13:08:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020 18:41:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 11:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per Pi this is a
related event.
Oct-26-2020 19:44:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Enlarged interior
neck lymph node:
Start date 12 days
post vaccination,
please confirm
relatedness
assessment.
Oct-19-2020 13:08:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae4093\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-2021-5683-0940995
Page 147 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-24-2020 14:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Nov-24-2020 13:56:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This is still ongoing
Nov-24-2020 13:06:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Can you
please confirm the
AE "enlarged left
interior neck lymph
node" is still
ongoing, else
update the outcome
of AE. Thanks
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae4093\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) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940996
Page 148 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-16-2020 16:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940997
Page 149 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site soreness left armInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 13:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4093\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-2021-5683-0940998
Page 150 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-16-2020 16:58:49
(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
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-22-2020 06:39:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-21-2020 09:40:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-21-2020 09:40:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NONew Information
Oct-19-2020 05:17:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for Data item#8 and
9 are missing.
Kindly review and
update.
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 09:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae4093\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) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940999
Page 151 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 16:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\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-2021-5683-0941000
Page 152 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
muscle achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4093\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-2021-5683-0941001
Page 153 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 23:46:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Oct-19-2020 13:09:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-19-2020 13:09:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
Oct-19-2020 05:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is
missing. Kindly
review and update.
090177e196ae4093\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) (4),
(b) (6)
FDA-CBER-2021-5683-0941002
Page 154 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 17:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\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-2021-5683-0941003
Page 155 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 17:01:31
(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
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperature, tempe
rature 99.1Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4093\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-2021-5683-0941004
Page 156 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 23:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Oct-19-2020 13:09:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-19-2020 13:09:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
Oct-19-2020 05:20:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is
missing. Kindly
review and update.
090177e196ae4093\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) (4),
(b) (6)
FDA-CBER-2021-5683-0941005
Page 157 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 17:01:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\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-2021-5683-0941006
Page 158 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 17:11:50
(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
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Myalgia in Entire BackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/17/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/19/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4093\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-2021-5683-0941007
Page 159 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-13-2020 17:11:50
(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
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\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-2021-5683-0941008
Page 160 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-13-2020 17:11:50
(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
Nov-13-2020 17:11:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941009
Page 161 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 17:12:32
(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
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Sided Upper Back PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/17/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/17/2020 11:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae4093\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-2021-5683-0941010
Page 162 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-13-2020 17:12:32
(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
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Physical ExertionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4093\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-2021-5683-0941011
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-13-2020 17:12:32
(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
Nov-13-2020 17:12:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\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-2021-5683-0941012
Page 164 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 17:13:01
(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
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 11:50:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Nov-23-2020 09:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-23-2020 09:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 16:00New Information
Nov-23-2020 08:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Event is
deemed related to
study treatment but
start time is prior to
vaccination time.
Please review if any
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941013
Page 165 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
updates are
required. Otherwise,
please clarify.
Nov-19-2020 20:28:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Candidate GPDCLIN: Event is
deemed related to
study treatment but
start time is prior to
vaccination time.
Please review if any
updates are
required. Otherwise,
please clarify.
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 11:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/19/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020 17:13:01
(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
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941014
Page 166 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae4093\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-2021-5683-0941015
Page 167 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 17:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941016
Page 168 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941017
Page 169 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Influenza VaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-13-2020 17:09:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941018
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Nov-13-2020 17:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-13-2020 17:09:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020 17:09:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941019
Page 171 of 175
***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: 11411230 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-28-2021 11:22:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941020
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 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
Feb-15-2021 06:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 21:14:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-28-2021 11:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-28-2021 11:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941021
Page 173 of 175
***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: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021 06:49:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-15-2021 06:49:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0941022
Page 174 of 175
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-13-2020 17:09:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-18-2020 10:45:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-18-2020 10:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-13-2020 17:09:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/13/2020Initial Entry
Sep-18-2020 10:45:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Initial Entry
Sep-18-2020 10:37:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Initial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941023
Page 175 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 16:06:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
WinokurData Entry:
Click Here to EnableInitial Entry
090177e196ae4093\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0941024