125742 S1 M5 CRF c4591001 1141 11411153

Document text

Page 1 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940337
Page 2 of 280
***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: 11411153 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
Aug/31/2020
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940338
Page 3 of 280
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411153]
2.Birth Date: /1978
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940339
Page 4 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940340
Page 5 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940341
Page 6 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940342
Page 7 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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:[chronic back pain]
Start Date: UNK/UNK/2002
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spinal fusion]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spondylolisthesis]
Start Date: UNK/UNK/2002
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940343
Page 8 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraines]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: Oct/2/2020
Ongoing: NO
End Date:
Jan/6/2021
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cardiac ablation ]
Start Date: Nov/20/2020
Ongoing: NO
End Date:
Nov/20/2020
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940344
Page 9 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cardiac ablation ]
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/2021
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pacemaker placement ]
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/2021
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Failed back surgical syndrome]
Start Date: Oct/UNK/2016
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spine surgery]
Start Date: Jun/UNK/1992
Ongoing: NO
End Date:
Jun/UNK/1992
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940345
Page 10 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spine surgery]
Start Date: Aug/UNK/2004
Ongoing: NO
End Date:
Aug/UNK/2004
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spine surgery]
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2005
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spine surgery]
Start Date: May/UNK/2010
Ongoing: NO
End Date:
May/UNK/2010
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spinal neurostimulator lead bilateral insertion]
Start Date: Feb/10/2017
Ongoing: NO
End Date:
Feb/10/2017
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940346
Page 11 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[scoliosis]
Start Date: UNK/UNK/2002
Ongoing: YES
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spinal cord stimulator bilateral implantation]
Start Date: Oct/UNK/2016
Ongoing: NO
End Date:
Oct/UNK/2016
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[removal of spinal cord stimulator]
Start Date: Jun/21/2019
Ongoing: NO
End Date:
Jun/21/2019
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940347
Page 12 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [53.2]
3.Unit: kg
4.Height: [164.1]
5.Unit: cm
6.Body Mass Index: [19.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940348
Page 13 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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: Aug/31/2020
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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940349
Page 14 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [75258]
3.Randomization Group: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940350
Page 15 of 280
***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: 11411153 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:
Aug/31/2020
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 [BM88V8]
5.bSample ID [BM88V9]
5.cSample ID [BM88VB]
5.dSample ID [BLC9CN]
5.eSample ID [BLC9CP]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940351
Page 16 of 280
***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: 11411153 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:
Aug/31/2020
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 [BM88V4]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940352
Page 17 of 280
***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: 11411153 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: Aug/31/2020 13:15
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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940353
Page 18 of 280
***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: 11411153 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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940354
Page 19 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940355
Page 20 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940356
Page 21 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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/21/2020
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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940357
Page 22 of 280
***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: 11411153 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/21/2020
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 [BM6J1L]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940358
Page 23 of 280
***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: 11411153 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/21/2020 11:36
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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940359
Page 24 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940360
Page 25 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP9M90]
5.bSample ID [BRX71R]
5.cSample ID [BRX71V]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940361
Page 26 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940362
Page 27 of 280
***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: 11411153 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: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940363
Page 28 of 280
***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: 11411153 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 [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940364
Page 29 of 280
***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: 11411153 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 [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940365
Page 30 of 280
***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: 11411153 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?
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940366
Page 31 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940367
Page 32 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940368
Page 33 of 280
***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: 11411153 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 [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940369
Page 34 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940370
Page 35 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940371
Page 36 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940372
Page 37 of 280
***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: 11411153 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: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940373
Page 38 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940374
Page 39 of 280
***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: 11411153 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 [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940375
Page 40 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Lightheadedness  Oct/2/2020 19:00  YES  Repeating
Pages
 2.ADVERSE E
VENT 2  Tachycardia  Oct/3/2020 UNK:UN
K YES  Repeating
Pages
 3.ADVERSE E
VENT 3  Junctional ectopic tac
hycardia Oct/2/2020 UNK:UN
K NO
End Date Time:
Jan/6/2021 UNK:UNK
 Repeating
Pages
 4.ADVERSE E
VENT 4  Fatigue  Feb/10/2021 10:00  NO
End Date Time:
Feb/14/2021 UNK:UN
K
 Repeating
Pages
 5.ADVERSE E
VENT 5  Nasal Congestion  Feb/11/2021 07:30  NO
End Date Time:
Feb/14/2021 UNK:UN
K
 Repeating
Pages
 6.ADVERSE E
VENT 6  Headache  Feb/11/2021 07:30  NO
End Date Time:
Feb/14/2021 UNK:UN
K
 Repeating
Pages
 7.ADVERSE E
VENT 7  Runny nose  Feb/11/2021 07:30  NO
End Date Time:
Feb/14/2021 UNK:UN
K
 Repeating
Pages
 8.ADVERSE E
VENT 8  Sinus Tachycardia  Jan/13/2021 UNK:U
NK YES  Repeating
Pages
 9.ADVERSE E
VENT 9  Near symcopal episod
e UNK/UNK/2021 UN
K:UNK NO
End Date Time:
UNK/UNK/2021 UNK:Repeating
Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940376
Page 41 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
UNK
 
 10.ADVERSE E
VENT 10  Dizziness  Jan/14/2021 UNK:U
NK NO
End Date Time:
Jan/29/2021 UNK:UN
K
 Repeating
Pages
 11.ADVERSE E
VENT 11  Headache  Jan/14/2021 UNK:U
NK NO
End Date Time:
Jan/29/2021 UNK:UN
K
 Repeating
Pages
 12.ADVERSE E
VENT 12  Lightheadedness  Jan/14/2021 UNK:U
NK NO
End Date Time:
Jan/29/2021 UNK:UN
K
 Repeating
Pages
 13.ADVERSE E
VENT 13  Headache  Feb/15/2021 UNK:U
NK NO
End Date Time:
Feb/25/2021 UNK:UN
K
 Repeating
Pages
 14.ADVERSE E
VENT 14  Dizziness  Feb/15/2021 UNK:U
NK NO
End Date Time:
Feb/25/2021 UNK:UN
K
 Repeating
Pages
 15.ADVERSE E
VENT 15  Fatigue  Feb/15/2021 UNK:U
NK NO
End Date Time:
Feb/25/2021 UNK:UN
K
 Repeating
Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940377
Page 42 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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)[Lightheadedness]
4.Start Date Time: Oct/2/2020 19:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[supraventricular tachycardia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940378
Page 43 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940379
Page 44 of 280
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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)[Tachycardia]
4.Start Date Time: Oct/3/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[supraventricular tachycardia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940380
Page 45 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940381
Page 46 of 280
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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)[Junctional ectopic tachycardia]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940382
Page 47 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Aberrant cardiac ectopic rhythm locus]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021138943]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940383
Page 48 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Feb/10/2021 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940384
Page 49 of 280
***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: 11411153 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[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940385
Page 50 of 280
***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: 11411153 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)[Nasal Congestion]
4.Start Date Time: Feb/11/2021 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[URI]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940386
Page 51 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940387
Page 52 of 280
***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: 11411153 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)[Headache]
4.Start Date Time: Feb/11/2021 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[URI]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940388
Page 53 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940389
Page 54 of 280
***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: 11411153 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)[Runny nose]
4.Start Date Time: Feb/11/2021 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[URI]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940390
Page 55 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940391
Page 56 of 280
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Sinus Tachycardia]
4.Start Date Time: Jan/13/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Underlying cardiac disturbance]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940392
Page 57 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940393
Page 58 of 280
***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: 11411153 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: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Near symcopal episode]
4.Start Date Time: UNK/UNK/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
UNK/UNK/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[likely related to patient's tachycardia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940394
Page 59 of 280
***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: 11411153 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[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940395
Page 60 of 280
***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: 11411153 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: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940396
Page 61 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940397
Page 62 of 280
***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: 11411153 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: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940398
Page 63 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940399
Page 64 of 280
***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: 11411153 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: [12]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lightheadedness]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940400
Page 65 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940401
Page 66 of 280
***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: 11411153 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: [13]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Feb/15/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/25/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940402
Page 67 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940403
Page 68 of 280
***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: 11411153 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: [14]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Feb/15/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/25/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940404
Page 69 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940405
Page 70 of 280
***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: 11411153 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: [15]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Feb/15/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/25/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940406
Page 71 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940407
Page 72 of 280
***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: 11411153 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 A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940408
Page 73 of 280
***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: 11411153 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[ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940409
Page 74 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940410
Page 75 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940411
Page 76 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940412
Page 77 of 280
***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: 11411153 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?
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940413
Page 78 of 280
***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: 11411153 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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940414
Page 79 of 280
***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: 11411153 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?
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940415
Page 80 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940416
Page 81 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940417
Page 82 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940418
Page 83 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940419
Page 84 of 280
***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: 11411153 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:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940420
Page 85 of 280
***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: 11411153 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?
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940421
Page 86 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940422
Page 87 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940423
Page 88 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940424
Page 89 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940425
Page 90 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940426
Page 91 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940427
Page 92 of 280
***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: 11411153 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: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940428
Page 93 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940429
Page 94 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/9/2021
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940430
Page 95 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940431
Page 96 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940432
Page 97 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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: Feb/9/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940433
Page 98 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLFZMK]
5.bSample ID [BLFZML]
5.cSample ID [BRFDS8]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940434
Page 99 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFDS7]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940435
Page 100 of 280
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 15:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940436
Page 101 of 280
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940437
Page 102 of 280
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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: Mar/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940438
Page 103 of 280
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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:
Mar/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFDWJ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940439
Page 104 of 280
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/2/2021 12:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940440
Page 105 of 280
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940441
Page 106 of 280
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940442
Page 107 of 280
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940443
Page 108 of 280
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940444
Page 109 of 280
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940445
Page 110 of 280
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940446
Page 111 of 280
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940447
Page 112 of 280
***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: 11411153 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 Oct/19/2020
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940448
Page 113 of 280
***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: 11411153 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
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940449
Page 114 of 280
***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: 11411153 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 Mar-08-2021 10:12:30 (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.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940450
Page 115 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-31-2020 13:48:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940451
Page 116 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-12-2021 06:44:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940452
Page 117 of 280
***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: 11411153 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 Mar-08-2021 10:12:30 (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 Mar-05-2021 12:19:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Mar-05-2021 10:58:56 (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 Mar-02-2021 16:38:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-24-2021 08:06:33 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940453
Page 118 of 280
***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: 11411153 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 Feb-19-2021 13:11:01 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-18-2021 13:02:51 (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.
 N/A Feb-15-2021 10:01:07 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-15-2021 09:42:50 (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.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940454
Page 119 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
 N/A Feb-15-2021 02:36:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-12-2021 13:04:03 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-10-2021 05:58:06 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-02-2020 15:57:34 (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.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940455
Page 120 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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
Aug-31-2020 13:48:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 13:48:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940456
Page 121 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 13:48:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940457
Page 122 of 280
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 13:48:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11411153Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 13:48:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1978Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 13:48:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 13:48:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 13:48:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940458
Page 123 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 13:48:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940459
Page 124 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 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
Aug-31-2020 13:49:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 13:49:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 13:49:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940460
Page 125 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 13:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:chronic back p
ain
Start Date: UNK/UNK/20
02
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
chronic back painInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 13:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 13:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae408f\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-2021-5683-0940461
Page 126 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-31-2020 13:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:spinal fusion
Start Date: UNK/UNK/199
2
Ongoing: NO
End Date:
UNK/UNK/
1992Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
spinal fusionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 13:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 13:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1992Initial Entry
090177e196ae408f\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-2021-5683-0940462
Page 127 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c
Date Location User Value Reason
Aug-31-2020 13:50:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 3
Medical History Te
rm:spondylolisthe
sis
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
Aug-31-2020 13:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:spondylolisthe
sis
Start Date: UNK/UNK/2
002
Ongoing:Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940463
Page 128 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
spondylolisthesisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 13:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 13:50:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-31-2020 13:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:depression
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae408f\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-2021-5683-0940464
Page 129 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 13:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 13:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-31-2020 13:51:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:anxiety
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae408f\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-2021-5683-0940465
Page 130 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:51:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:51:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-31-2020 13:51:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-31-2020 13:51:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-31-2020 13:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:migraines
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
090177e196ae408f\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-2021-5683-0940466
Page 131 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-31-2020 13:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 13:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
migrainesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-31-2020 13:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-31-2020 13:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Te
rm:
Start Date: Oct/2/2020
Ongoing: NO
End Date:
Jan/6/20
21entered as AE
(DELETED)
Feb-23-2021 14:14:42
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number:already entered as
AE
090177e196ae408f\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)
FDA-CBER-2021-5683-0940467
Page 132 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Medical History Te
rm:
Start Date: Oct/2/2020
Ongoing: NO
End Date:
Jan/6/20
21
Feb-19-2021 13:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:junctional ectopic
tachycardia
Start Date: Oct/2/2020
Ongoing: NO
End Date:
Jan/6/2021Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940468
Page 133 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: entered as AE
(DELETED)
Feb-23-2021 14:14:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: already entered as
AE
Feb-19-2021 13:11:01
(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
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: entered as AE
(DELETED)
Feb-23-2021 14:14:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: already entered as
AE
Feb-19-2021 13:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
junctional ectopic tachycardiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Feb-24-2021 06:21:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 02:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-23-2021 14:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this had been entered
as an AE and deleted
from medical history
source
Feb-23-2021 14:15:09
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Oct/2/2020entered as AE
(DELETED)
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940469
Page 134 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-21-2021 23:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: If event occur
post vaccination then
it needs to be
consider as an AE.
Kindly verify and
consider updating
data as appropriate.
Thank you.
Feb-19-2021 13:11:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered added in for
pertinent medical
history
Feb-19-2021 13:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
Feb-19-2021 13:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae408f\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)
FDA-CBER-2021-5683-0940470
Page 135 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.g Ongoing:
Date Location User Value Reason
Feb-23-2021 14:15:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021entered as AE
(DELETED)
Feb-19-2021 13:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021Initial Entry
1.h
Date Location User Value Reason
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:8
Medical History T
erm:cardiac ablati
on
Start Date: Nov/20/2020
Ongoing: NO
End Date:
Nov/20/2
020entered in as AE
(DELETED)
Feb-19-2021 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:cardiac ablati
on
Start Date: Nov/20/2020
Ongoing: NO
End Date:
Nov/20/2
020Initial Entry
090177e196ae408f\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-2021-5683-0940471
Page 136 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.h Line/MH Number:
Date Location User Value Reason
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
8entered in as AE
(DELETED)
Feb-19-2021 13:12:52
(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
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cardiac ablationentered in as AE
(DELETED)
Feb-19-2021 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cardiac ablationInitial Entry
1.h Start Date:
Date Location User Value Reason
Feb-24-2021 10:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Data strikethrough.
Feb-24-2021 03:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-23-2021 14:24:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this had been entered
as an AE and deleted
from medical history
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020entered in as AE
(DELETED)
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940472
Page 137 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-21-2021 23:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: If event occur
post vaccination then
it needs to be
consider as an AE.
Kindly verify and
consider updating
data as appropriate.
Thank you.
Feb-19-2021 13:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Feb-19-2021 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
Feb-19-2021 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Feb-23-2021 14:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/20/2020entered in as AE
(DELETED)
Feb-19-2021 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/20/2020Initial Entry
1.i
Date Location User Value Reason
Feb-23-2021 14:15:49
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Line/MH Number 9entered in as AE
(DELETED)
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940473
Page 138 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) :
Medical History T
erm:cardiac ablati
on
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/202
1
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:cardiac ablati
on
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/202
1Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940474
Page 139 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
9entered in as AE
(DELETED)
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cardiac ablationentered in as AE
(DELETED)
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cardiac ablationInitial Entry
1.i Start Date:
Date Location User Value Reason
Feb-24-2021 10:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Data strikethrough.
Feb-24-2021 03:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-23-2021 14:25:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this had already been
entered as SAE and
deleted from MH
source
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021entered in as AE
(DELETED)
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940475
Page 140 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-21-2021 23:16:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: If event occur
post vaccination then
it needs to be
consider as an AE.
Kindly verify and
consider updating
data as appropriate.
Thank you.
Feb-19-2021 13:14:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
1.i Ongoing:
Date Location User Value Reason
Feb-23-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021entered in as AE
(DELETED)
Feb-19-2021 13:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021Initial Entry
1.j
Date Location User Value Reason
Feb-23-2021 14:16:08
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Line/MH Numb 10entered in as AE
(DELETED)
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940476
Page 141 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) er:
Medical Histor
y Term:pacemaker plac
ement
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/2021
Feb-19-2021 13:15:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical Histor
y Term:pacemaker plac
ement
Start Date: Jan/6/2021
Ongoing: NO
End Date:
Jan/6/2021Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940477
Page 142 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.j Line/MH Number:
Date Location User Value Reason
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10entered in as AE
(DELETED)
Feb-19-2021 13:15:36
(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
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pacemaker placemententered in as AE
(DELETED)
Feb-19-2021 13:15:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pacemaker placementInitial Entry
1.j Start Date:
Date Location User Value Reason
Feb-24-2021 06:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 02:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-23-2021 14:26:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this had been entered
as an SAE and
deleted from medical
history source
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021entered in as AE
(DELETED)
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020. Please
review and update as
appropriate.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940478
Page 143 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940479
Page 144 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.j Start Date:
Date Location User Value Reason
Feb-22-2021 05:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: If event occur
post vaccination
then it needs to be
consider as an AE.
Kindly verify and
consider updating
data as appropriate.
Thank you.
Feb-19-2021 13:15:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Feb-19-2021 13:15:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020.
Please review and
update as
appropriate.
Feb-19-2021 13:15:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
1.j Ongoing:
Date Location User Value Reason
Feb-23-2021 14:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021entered in as AE
(DELETED)
Feb-19-2021 13:15:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/6/2021Initial Entry
1.k
Date Location User Value Reason
090177e196ae408f\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-2021-5683-0940480
Page 145 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-19-2021 13:30:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:Failed back surgica
l syndrome
Start Date: Oct/UNK/2016
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:30:53
(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 Value Reason
Feb-19-2021 13:30:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Failed back surgical syndromeInitial Entry
1.k Start Date:
Date Location User Value Reason
Feb-19-2021 13:30:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
Feb-19-2021 13:30:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Feb-19-2021 13:31:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:12Initial Entry
090177e196ae408f\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-2021-5683-0940481
Page 146 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medical History T
erm:spine surgery
Start Date: Jun/UNK/1992
Ongoing: NO
End Date:
Jun/UNK/1
992
1.l Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:31:37
(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
Feb-19-2021 13:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spine surgeryInitial Entry
1.l Start Date:
Date Location User Value Reason
Feb-19-2021 13:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/1992Initial Entry
1.l Ongoing:
Date Location User Value Reason
Feb-19-2021 13:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/UNK/1992Initial Entry
1.m
Date Location User Value Reason
Feb-19-2021 13:32:19
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae408f\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-2021-5683-0940482
Page 147 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) Line/MH Number
:13
Medical History T
erm:spine surgery
Start Date: Aug/UNK/200
4
Ongoing: NO
End Date:
Aug/UNK/2
004
1.m Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:32:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 13:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spine surgeryInitial Entry
1.m Start Date:
Date Location User Value Reason
Feb-19-2021 13:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2004Initial Entry
1.m Ongoing:
Date Location User Value Reason
Feb-19-2021 13:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/UNK/2004Initial Entry
1.n
090177e196ae408f\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-2021-5683-0940483
Page 148 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-19-2021 13:33:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:14
Medical History T
erm:spine surgery
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2
005Initial Entry
1.n Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:33:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 13:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spine surgeryInitial Entry
1.n Start Date:
Date Location User Value Reason
Feb-19-2021 13:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2005Initial Entry
1.n Ongoing:
Date Location User Value Reason
Feb-19-2021 13:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/UNK/2005Initial Entry
090177e196ae408f\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-2021-5683-0940484
Page 149 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.o
Date Location User Value Reason
Feb-19-2021 13:34:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:15
Medical History T
erm:spine surgery
Start Date: May/UNK/201
0
Ongoing: NO
End Date:
May/UNK/2
010Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940485
Page 150 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.o Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:34:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 13:34:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spine surgeryInitial Entry
1.o Start Date:
Date Location User Value Reason
Feb-19-2021 13:34:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2010Initial Entry
1.o Ongoing:
Date Location User Value Reason
Feb-19-2021 13:34:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/UNK/2010Initial Entry
1.p
Date Location User Value Reason
Feb-22-2021 13:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:16
Medical H
istory Ter
m:spinal neurostimulato
r lead bilateral inserti
on
Start Date
:Feb/10/2017Changed
Information
090177e196ae408f\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)
FDA-CBER-2021-5683-0940486
Page 151 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
Feb/10/2017
Feb-22-2021 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:16
Medical H
istory Ter
m:spinal neurostimulato
r lead bilateral inserti
on
Start Date
:Feb/10/2017
Ongoing: NO
End Date:
Jun/UNK/2019New Information
Feb-19-2021 13:35:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:16
Medical His
tory Term:spinal neurostimula
tor lead bilateral
Start Date: Feb/10/2017
Ongoing: NO
End Date:
Jun/UNK/2019Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940487
Page 152 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.p Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:35:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-22-2021
10:12:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Cl
osedDiscrepancy has been
closed.
Feb-22-2021
08:51:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredNew Information
Feb-22-2021
08:51:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
spinal neur
ostimulator
lead bilater
al insertionNew Information
Feb-21-2021
11:18:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: O
penedClarify SPINAL
NEUROSTIMULATOR
LEAD BILATERAL as
follows...Are you
reproting INSERTION?
REMOVAL?
DISLOCATION? Or
CENTRAL NERVOUS
SYSTEM
STIMULATION
PROCEDURE? Or
other? Please update the
verbatim term to clarify.
Thank you.
Feb-21-2021
11:10:22
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Cl
osedDiscrepancy has been
closed.
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940488
Page 153 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
Feb-21-2021
05:40:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: O
penedClarify SPINAL
NEUROSTIMULATOR
LEAD BILATERAL as
follows...Term is
unclear. If reporting
SPINAL
NEUROSTIMULATOR
IMPLANTATION
BILATERAL, please
update the verbatim
term as such. Otherwise
clarify LEAD further
and update the term as
appropriate. Thank you.
Feb-21-2021
04:41:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has been
closed.
Feb-19-2021
17:15:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedClarify SPINAL
NEUROSTIMULATOR
LEAD BILATERAL as
follows...Term is
unclear. If reporting
SPINAL
NEUROSTIMULATOR
IMPLANTATION
BILATERAL, please
update the verbatim
term as such. Otherwise
clarify LEAD further
and update the term as
appropriate. Thank you.
Feb-19-2021
13:35:10
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
spinal neur
ostimulator
lead bilater
alInitial Entry
1.p Start Date:
Date Location User Value Reason
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940489
Page 154 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-19-2021 13:35:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2017Initial Entry
1.p Ongoing:
Date Location User Value Reason
Feb-23-2021 15:29:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-22-2021 13:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-22-2021 13:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/10/2017Changed Information
Feb-22-2021 10:20:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Spinal
Neurostimulator
Lead Bilateral
Insertion is noted
from 10Feb2017 to
Jun2019. However,
this is a procedure
and should only be 1
day in duration.
Please confirm the
END DATE and
update the CRF as
appropriate
Feb-19-2021 13:35:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/UNK/2019Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0940490
Page 155 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.q
Date Location User Value Reason
Feb-19-2021 13:35:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:scoliosis
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.q Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:35:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 13:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
scoliosisInitial Entry
1.q Start Date:
Date Location User Value Reason
Feb-19-2021 13:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.q Ongoing:
Date Location User Value Reason
Feb-19-2021 13:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
090177e196ae408f\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-2021-5683-0940491
Page 156 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-22-2021 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:18
Medical H
istory Ter
m:spinal cord stimulato
r bilateral implantati
on
Start Date
:Oct/UNK/2016
Ongoing: NO
End Date:
Oct/UNK/2016Changed
Information
Feb-19-2021 13:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:18
Medical H
istory Ter
m:spinal cord stimulato
r bilateral implantati
on
Start Date
:Oct/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940492
Page 157 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.r Line/MH Number:
Date Location User Value Reason
Feb-19-2021 13:36:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 13:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spinal cord stimulator bilateral im
plantationInitial Entry
1.r Start Date:
Date Location User Value Reason
Feb-19-2021 13:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2016Initial Entry
1.r Ongoing:
Date Location User Value Reason
Feb-23-2021 15:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-22-2021 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-22-2021 13:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/UNK/2016Changed
Information
Feb-22-2021 10:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Spinal
Cord Stimulator
Bilateral
Implantation is
noted from Oct2016
to 2019. However,
this is a procedure
and should only be 1
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0940493
Page 158 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
day in duration.
Please confirm the
END DATE and
update the CRF as
appropriate
Feb-19-2021 13:36:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.s
Date Location User Value Reason
Feb-22-2021 08:55:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:19
Medical Hist
ory Term:removal of spinal co
rd stimulator
Start Date: Jun/21/2019
Ongoing: NO
End Date:
Jun/21/2019Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940494
Page 159 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.s Line/MH Number:
Date Location User Value Reason
Feb-22-2021 08:55:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-22-2021 08:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
removal of spinal cord stimulatorInitial Entry
1.s Start Date:
Date Location User Value Reason
Feb-22-2021 08:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/21/2019Initial Entry
1.s Ongoing:
Date Location User Value Reason
Feb-22-2021 08:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/21/2019Initial Entry
090177e196ae408f\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-2021-5683-0940495
Page 160 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
53.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
164.1Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19.8Initial Entry
090177e196ae408f\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-2021-5683-0940496
Page 161 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.2
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
99.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 13:51:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae408f\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-2021-5683-0940497
Page 162 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940498
Page 163 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940499
Page 164 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 13:52:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 09:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-02-2020 08:03:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-02-2020 08:03:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
75258Transcription Error
Sep-02-2020 05:17:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Randomization
number recorded at
impala 75258 is not
matching with
number recorded at
inform. Please
review and update
data as appropriate.
Else, clarify. Thank
you.
Aug-31-2020 13:52:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
75288Initial Entry
090177e196ae408f\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-2021-5683-0940500
Page 165 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 13:52:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 13:52:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 05:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 13:52:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-31-2020 13:52:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 05:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88V8Initial Entry
5.a Sample ID
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940501
Page 166 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-01-2020 05:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM88V8Initial Entry
5.b
Date Location User Value Reason
Sep-01-2020 05:50:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88V9Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 05:50:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM88V9Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020 05:51:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88VBInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 05:51:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM88VBInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 05:51:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC9CNInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940502
Page 167 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 05:51:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC9CNInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 05:51:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC9CPInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 05:51:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC9CPInitial Entry
090177e196ae408f\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-2021-5683-0940503
Page 168 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 13:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 13:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 05:51:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 13:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-31-2020 13:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 05:51:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88V4Initial Entry
5.a Sample ID
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940504
Page 169 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-01-2020 05:51:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM88V4Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940505
Page 170 of 280
***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: 11411153 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
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020 13:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae408f\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-2021-5683-0940506
Page 171 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 13:52:51
(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
Aug-31-2020 13:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940507
Page 172 of 280
***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: 11411153 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
Aug-31-2020 13:52:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940508
Page 173 of 280
***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: 11411153 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-21-2020 16:49:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940509
Page 174 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.0
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae408f\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-2021-5683-0940510
Page 175 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 16:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940511
Page 176 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020 16:49:47
(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-21-2020 16:49:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020 16:49:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 16:49:47
(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-21-2020 16:49:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-21-2020 16:49:47
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940512
Page 177 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 16:49:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020 16:49:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020 16:49:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940513
Page 178 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 16:49:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 16:49:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 06:38:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 01:46:08
(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-21-2020 16:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-21-2020 16:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940514
Page 179 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-22-2020 06:38:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM6J1LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 06:38:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM6J1LInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940515
Page 180 of 280
***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: 11411153 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-21-2020 16:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 16:50:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 16:50:19
(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-21-2020 16:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 11:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 16:50:19
(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-21-2020 16:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae408f\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-2021-5683-0940516
Page 181 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Sep-21-2020 16:50:19
(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-21-2020 16:50:19
(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-21-2020 16:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940517
Page 182 of 280
***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: 11411153 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-19-2020 16:35:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940518
Page 183 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 16:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 16:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 06:21:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 16:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-19-2020 16:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 06:21:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9M90Initial Entry
5.a Sample ID
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940519
Page 184 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-20-2020 06:21:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9M90Initial Entry
5.b
Date Location User Value Reason
Oct-20-2020 06:21:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX71RInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 06:21:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRX71RInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 06:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX71VInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 06:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRX71VInitial Entry
090177e196ae408f\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-2021-5683-0940520
Page 185 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 16:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 16:36:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 16:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940521
Page 186 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940522
Page 187 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-21-2020 09:35:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940523
Page 188 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-12-2021 12:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940524
Page 189 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 09:56:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940525
Page 190 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 09:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940526
Page 191 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:00:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940527
Page 192 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:03:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940528
Page 193 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:08:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940529
Page 194 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940530
Page 195 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940531
Page 196 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:22:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940532
Page 197 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:24:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940533
Page 198 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:25:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940534
Page 199 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:26:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940535
Page 200 of 280
***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: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-04-2021 10:28:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae408f\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940536
Page 201 of 280
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-21-2020 09:27:41
(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-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LightheadednessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 19:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 15:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered addressed this as
related to condition
Oct-25-2020 20:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Lightheadedness: AE
start date is 32 days
post vax 1 and 11
days post vax 2.
Please confirm
relatedness to study
treatment.
Oct-21-2020 09:27:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 19:00Initial Entry
090177e196ae408f\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-2021-5683-0940537
Page 202 of 280
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-21-2020 09:27:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 15:46:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHERNew Information
090177e196ae408f\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-2021-5683-0940538
Page 203 of 280
***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, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411153 S
…[truncated]