125742 S1 M5 CRF c4591001 1141 11411221

Document text

Page 1 of 233
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940617
Page 2 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/16/2020
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940618
Page 3 of 233
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411221]
2.Birth Date: /1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940619
Page 4 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940620
Page 5 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940621
Page 6 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940622
Page 7 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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:[Endometrial Ablation]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendectomy]
Start Date: May/UNK/2012
Ongoing: NO
End Date:
May/UNK/2012
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940623
Page 8 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendicitis]
Start Date: May/UNK/2012
Ongoing: NO
End Date:
May/UNK/2012
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940624
Page 9 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [72.6]
3.Unit: kg
4.Height: [159.8]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940625
Page 10 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940626
Page 11 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [91630]
3.Randomization Group: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940627
Page 12 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM6HZW]
5.bSample ID [BLC9J4]
5.cSample ID [BLC9J5]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940628
Page 13 of 233
***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: 11411221 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/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM6HZS]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940629
Page 14 of 233
***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: 11411221 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/16/2020 15:19
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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940630
Page 15 of 233
***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: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940631
Page 16 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940632
Page 17 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940633
Page 18 of 233
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
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:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940634
Page 19 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BP9M5N]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940635
Page 20 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/7/2020 15:10
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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940636
Page 21 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940637
Page 22 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BP9MF2]
5.bSample ID [BRX788]
5.cSample ID [BRX789]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940638
Page 23 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940639
Page 24 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/22/2020
2.Date of First Symptom Started: Dec/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/2/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940640
Page 25 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [rhinorrhea]
5.bSymptoms - Other Text: [foggy thinking]
5.cSymptoms - Other Text: [nausea]
5.dSymptoms - Other Text: [headache]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940641
Page 26 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/22/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940642
Page 27 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/22/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940643
Page 28 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
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: 11411221 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_SELF
3.Sample Collected? YES
Date of Collection:
Dec/22/2020
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 [RW87825]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940644
Page 29 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: 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: 11411221 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Swab not collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940645
Page 30 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940646
Page 31 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.Other Type of Practitioner
Specify:[Franklin General Hospital]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940647
Page 32 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940648
Page 33 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940649
Page 34 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/22/2020
3.Toxicity Grade: 2
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940650
Page 35 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940651
Page 36 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940652
Page 37 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940653
Page 38 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940654
Page 39 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940655
Page 40 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940656
Page 41 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940657
Page 42 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940658
Page 43 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940659
Page 44 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940660
Page 45 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940661
Page 46 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: OXYGENATION PARAMETERS
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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940662
Page 47 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940663
Page 48 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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.Start Date: //
6.Ongoing?
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940664
Page 49 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940665
Page 50 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940666
Page 51 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940667
Page 52 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/20/2021Form: 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: 11411221 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:
Jan/20/2021
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 [BLFZ52]
5.bSample ID [BLFZ51]
5.cSample ID [BP9LZZ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940668
Page 53 of 233
***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: 11411221 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:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940669
Page 54 of 233
***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: 11411221 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 [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940670
Page 55 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940671
Page 56 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940672
Page 57 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Fever (100.9 F)  Jan/21/2021
12:00 NO
End Date Time:
Jan/22/2021 12:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  chills  Jan/21/2021
12:00 NO
End Date Time:
Jan/22/2021 21:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  Fatigue  Jan/21/2021
12:00 NO
End Date Time:
Jan/22/2021 21:00
 Repeating
Pages
 4.ADVERSE E
VENT 4  left axillary lymph node
enlargement Jan/23/2021
10:00 NO
End Date Time:
Jan/25/2021 05:00
 Repeating
Pages
 5.ADVERSE E
VENT 5  headache  Feb/11/2021
07:00 NO
End Date Time:
Feb/12/2021 12:00
 Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940673
Page 58 of 233
***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: 11411221 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)[Fever (100.9 F)]
4.Start Date Time: Jan/21/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940674
Page 59 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940675
Page 60 of 233
***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: 11411221 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)[chills]
4.Start Date Time: Jan/21/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 21:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940676
Page 61 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940677
Page 62 of 233
***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: 11411221 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)[Fatigue]
4.Start Date Time: Jan/21/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 21:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940678
Page 63 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940679
Page 64 of 233
***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: 11411221 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)[left axillary lymph node enlargement]
4.Start Date Time: Jan/23/2021 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/25/2021 05:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940680
Page 65 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940681
Page 66 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 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)[headache]
4.Start Date Time: Feb/11/2021 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940682
Page 67 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940683
Page 68 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940684
Page 69 of 233
***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: 11411221 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[ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940685
Page 70 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart Da
teForm Instanc
e
 1.1  VACCINATION
S NO  Influenza Vacc
ination Oct/22/2
020 Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940686
Page 71 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Influenza Vaccination]
5.Date: Oct/22/2020
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940687
Page 72 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940688
Page 73 of 233
***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: 11411221 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?
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940689
Page 74 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940690
Page 75 of 233
***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: 11411221 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?
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940691
Page 76 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940692
Page 77 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940693
Page 78 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940694
Page 79 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940695
Page 80 of 233
***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: 11411221 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:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940696
Page 81 of 233
***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: 11411221 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:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940697
Page 82 of 233
***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: 11411221 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?
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940698
Page 83 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940699
Page 84 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940700
Page 85 of 233
***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: 11411221 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: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940701
Page 86 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940702
Page 87 of 233
***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: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940703
Page 88 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940704
Page 89 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940705
Page 90 of 233
***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: 11411221 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: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940706
Page 91 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940707
Page 92 of 233
***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: 11411221 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
Jan/20/2021
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940708
Page 93 of 233
***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: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940709
Page 94 of 233
***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: 11411221 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 :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940710
Page 95 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/20/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940711
Page 96 of 233
***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: 11411221 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[drawn for convalescent visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940712
Page 97 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BP9LZY]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940713
Page 98 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 15:10
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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940714
Page 99 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940715
Page 100 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940716
Page 101 of 233
***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: 11411221 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/10/2021
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 [BRFDSF]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940717
Page 102 of 233
***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: 11411221 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/10/2021 15:35
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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940718
Page 103 of 233
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940719
Page 104 of 233
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940720
Page 105 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940721
Page 106 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940722
Page 107 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940723
Page 108 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940724
Page 109 of 233
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940725
Page 110 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940726
Page 111 of 233
***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: 11411221 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
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940727
Page 112 of 233
***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: 11411221 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-12-2021 14:17:29 (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.
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940728
Page 113 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-16-2020 16:33:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940729
Page 114 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-20-2021 16:28:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940730
Page 115 of 233
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Feb-11-2021 15:03:27 (UTC-06:00) Central
Time (US & Canada)Hadley Mosby Not Applicable
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940731
Page 116 of 233
***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: 11411221 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-12-2021 14:17:29 (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-11-2021 12:35:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Mar-02-2021 15:35:48 (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 10:02:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940732
Page 117 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
Patricia
Winokur Approved Feb-12-2021 13:26:39 (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.
Hadley Mosby  N/A Feb-11-2021 15:02:37 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Jan-22-2021 17:42:02 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-20-2021 16:27:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Jan-04-2021 11:33:15 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940733
Page 118 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-28-2020 12:03:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-28-2020 08:36:25 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-22-2020 11:40:34 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-11-2020 18:58:20 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940734
Page 119 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, PatriciaWinokur, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-11-2020 16:01:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-06-2020 11:24:35 (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.
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940735
Page 120 of 233
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020 16:32:47
(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
Sep-16-2020 16:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940736
Page 121 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020 16:32:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/16/2020Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940737
Page 122 of 233
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 16:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11411221Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020 16:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020 16:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020 16:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4091\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-2021-5683-0940738
Page 123 of 233
***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: 11411221 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-16-2020 16:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940739
Page 124 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020 16:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 16:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020 16:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940740
Page 125 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 16:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Endometrial A
blation
Start Date: UNK/UNK/20
12
Ongoing: NO
End Date:
UNK/UNK/
2012Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Endometrial AblationInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 16:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940741
Page 126 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 16:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.b
Date Location User Value Reason
Sep-16-2020 16:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Post Menop
ausal
Start Date: UNK/UNK/
2012
Ongoing: YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940742
Page 127 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Post MenopausalInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 16:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 16:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-16-2020 16:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Appendectom
y
Start Date: May/UNK/20
12Initial Entry
090177e196ae4091\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-2021-5683-0940743
Page 128 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
May/UNK/
2012
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020 16:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020 16:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/UNK/2012Initial Entry
1.d
Date Location User Value Reason
Sep-16-2020 16:35:05 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae4091\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-2021-5683-0940744
Page 129 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Num
ber:4
Medical Histor
y Term:Appendicitis
Start Date: May/UNK/20
12
Ongoing: NO
End Date:
May/UNK/
2012
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940745
Page 130 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendicitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020 16:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020 16:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/UNK/2012Initial Entry
090177e196ae4091\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-2021-5683-0940746
Page 131 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
72.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
159.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae4091\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-2021-5683-0940747
Page 132 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.7
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae4091\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-2021-5683-0940748
Page 133 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-16-2020 16:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940749
Page 134 of 233
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 16:35:42
(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-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 16:35:42
(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-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940750
Page 135 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-16-2020 16:36:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONETranscription Error
Sep-16-2020 16:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done:: NOT DONEInitial Entry
Sep-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940751
Page 136 of 233
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020 16:36:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-16-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-16-2020 16:36:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-16-2020 16:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Not Done is
indicated however
result is provided.
Please correct or
clarify.
Sep-16-2020 16:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae4091\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-2021-5683-0940752
Page 137 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020 16:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Sep-18-2020
08:14:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed as data
updated.
Sep-17-2020
06:13:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Sep-17-2020
06:13:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
91630Transcription
Error
Sep-17-2020
02:46:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedAs per Impala,
Randomization
Number is
91630 . Please
review and
update as
appropriate.
"[
]"
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940753
Page 138 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-16-2020
16:36:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
9163Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940754
Page 139 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 16:36:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 16:36:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 06:13:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 03:27:24
(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-16-2020 16:36:37
(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-16-2020 16:36:37
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940755
Page 140 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Sep/16/2020
5.a
Date Location User Value Reason
Sep-17-2020 06:13:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM6HZWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 06:13:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM6HZWInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 06:13:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC9J4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 06:13:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLC9J4Initial Entry
5.c
Date Location User Value Reason
Sep-17-2020 06:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC9J5Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940756
Page 141 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 06:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLC9J5Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940757
Page 142 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 16:36:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 16:36:48
(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-17-2020 06:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 03:27:24
(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-16-2020 16:36:48
(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-16-2020 16:36:48
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940758
Page 143 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Sep/16/2020
5.a
Date Location User Value Reason
Sep-17-2020 06:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM6HZSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 06:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM6HZSInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940759
Page 144 of 233
***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: 11411221 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-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 16:37:03
(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-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 15:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940760
Page 145 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 16:37:03
(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-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 16:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940761
Page 146 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-16-2020 16:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940762
Page 147 of 233
***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: 11411221 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-07-2020 18:06:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940763
Page 148 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 96.7
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020 13:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-12-2020 15:12:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Not clinically
significant
Oct-09-2020 01:44:26 ACV0PFEINFP6000  Sandip Query 1: Reissued:Opened Kindly verify and
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940764
Page 149 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)Namdeorao
Suryawanshiconfirm if subject
is clinically
significant or
non-clinically
significant. Thank
you.
Oct-08-2020 14:31:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.7
F is outside of
Normal Range 97 -
99.5 F.
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 18:06:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940765
Page 150 of 233
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940766
Page 151 of 233
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020 18:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940767
Page 152 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 18:06:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 18:06:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 06:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 02:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-07-2020 18:06:39
(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-07-2020 18:06:39
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940768
Page 153 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Oct/7/2020
5.a
Date Location User Value Reason
Oct-08-2020 06:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9M5NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 06:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9M5NInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940769
Page 154 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 15:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940770
Page 155 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-07-2020 18:06:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940771
Page 156 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 16:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940772
Page 157 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 16:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 16:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 16:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-11-2020 16:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940773
Page 158 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-11-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9MF2Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9MF2Initial Entry
5.b
Date Location User Value Reason
Nov-11-2020 16:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX788Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020 16:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRX788Initial Entry
5.c
Date Location User Value Reason
Nov-11-2020 16:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX789Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020 16:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRX789Initial Entry
090177e196ae4091\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-2021-5683-0940774
Page 159 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-22-2020 12:02:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-22-2020 11:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-22-2020 11:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Dec-22-2020 11:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-22-2020 11:40:32
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940775
Page 160 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940776
Page 161 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-02-2021 13:43:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 10:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-02-2021 10:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Reso
lved:
Jan/2/2021New Information
Mar-01-2021 15:34:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: As subject
was recently
vaccinated on
20Jan2021, please
clarify whether the
reported
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940777
Page 162 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
symptoms are still
ongoing. If
symptoms have
ended, please
update ‘Symptoms
Ongoing’ to ‘NO’
and add Date of
Last Symptom
Resolved on the
CRF.
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940778
Page 163 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940779
Page 164 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.c Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940780
Page 165 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE P
AIN
Sympto
m Prese
nt:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940781
Page 166 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.f Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE THR
OAT
Sympto
m Prese
nt:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940782
Page 167 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.h
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940783
Page 168 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.i Symptoms:
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-22-2020 11:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-22-2020 11:42:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:rhinorrhe
aInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-22-2020 11:42:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
rhinorrheaInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 11:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:foggy think
ingInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940784
Page 169 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-22-2020 11:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
foggy thinkingInitial Entry
5.c
Date Location User Value Reason
Dec-22-2020 11:43:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: nauseaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-22-2020 11:43:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
nauseaInitial Entry
5.d
Date Location User Value Reason
Dec-22-2020 11:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other
:headach
eInitial Entry
5.d Symptoms - Other Text:
Date Location User Value Reason
Dec-22-2020 11:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940785
Page 170 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940786
Page 171 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940787
Page 172 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-22-2020 12:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UNKNOWNInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940788
Page 173 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 12:02:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 12:02:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 12:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-23-2020 06:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-22-2020 12:02:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-22-2020 12:02:54
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940789
Page 174 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Dec/22/2020
5.a
Date Location User Value Reason
Dec-28-2020 12:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: RW87825Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 12:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RW87825Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940790
Page 175 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 11:43:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 11:43:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 11:43:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-22-2020 11:43:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Swab not collected.Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940791
Page 176 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECI
ALIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGE
NCY ROO
M
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940792
Page 177 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940793
Page 178 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGEN
T CARE
Occurrence of Vis
its or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:TELEPHONE
CONSULTATI
ON
Occurrence o
f Visits or Co
ntacts:YES
Number of Vi
sits or Conta
cts:
1Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940794
Page 179 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts
:
1Initial Entry
1.f
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:OTHER
Occurrence o
f Visits or Co
ntacts:YES
Number of V
isits or Cont
acts:
1Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940795
Page 180 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-22-2020 12:06:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened “Other” is selected
, however other
specific item is
blank. Please
review and update
as appropriate.
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contact
s:
1Initial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Dec-22-2020 12:06:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Franklin General HospitalInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-22-2020 11:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940796
Page 181 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-22-2020 11:44:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-31-2020 10:40:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-30-2020 13:39:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-30-2020 13:39:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnos
is:
COVID-19
Date of Diagnosis:
Dec/22/2020New Information
Dec-30-2020 13:38:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Yes is selected,
however, either the
diagnosis details
or date of
diagnosis is
missing. Please
correct.
Dec-30-2020 13:38:27
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940797
Page 182 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/22/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Dec-30-2020 13:38:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Diagnosis:
Dec/22/2020New Information
Dec-30-2020 10:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: As subject is
symptomatic and
has a positive local
swab collected on
22Dec2020,
diagnosis of
COVID-19 should
be recorded.
Dec-22-2020 11:44:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-31-2020 00:49:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-30-2020 13:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-30-2020 13:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2New Information
Dec-23-2020 00:59:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Toxicity
Grade" is missing.
Kindly review and
update.
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940798
Page 183 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-20-2021 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940799
Page 184 of 233
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 16:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 16:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 16:30:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-20-2021 16:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-20-2021 16:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/20/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940800
Page 185 of 233
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-20-2021 16:30:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLFZ52Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021 16:30:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLFZ52Initial Entry
5.b
Date Location User Value Reason
Jan-20-2021 16:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLFZ51Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-20-2021 16:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLFZ51Initial Entry
5.c
Date Location User Value Reason
Jan-20-2021 16:31:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9LZZInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-20-2021 16:31:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9LZZInitial Entry
090177e196ae4091\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-2021-5683-0940801
Page 186 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hadley
MosbyForm Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940802
Page 187 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hadley
MosbyForm Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940803
Page 188 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hadley
MosbyForm Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940804
Page 189 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hadley
MosbyForm Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940805
Page 190 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940806
Page 191 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 15:15:19
(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
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
Fever (100.9 F)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
Jan/21/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NO
End Date Time:
Jan/22/2021 12:00Initial Entry
6. Toxicity Grade:
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940807
Page 192 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOT APPLICABLEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940808
Page 193 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 15:15:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940809
Page 194 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
Jan/21/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NO
End Date Time:
Jan/22/2021 21:00Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940810
Page 195 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Toxicity Grade:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOT APPLICABLEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940811
Page 196 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 15:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940812
Page 197 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
Jan/21/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NO
End Date Time:
Jan/22/2021 21:00Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940813
Page 198 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Toxicity Grade:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOT APPLICABLEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940814
Page 199 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 15:17:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940815
Page 200 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
left axillary lymph node enlarg
ementInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
Jan/23/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NO
End Date Time:
Jan/25/2021 05:00Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940816
Page 201 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Toxicity Grade:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOT APPLICABLEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940817
Page 202 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-11-2021 15:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hadley
MosbyData Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940818
Page 203 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/12/2021 12:00Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940819
Page 204 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 12:35:16
(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
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940820
Page 205 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 12:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0940821
Page 206 of 233
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940822
Page 207 of 233
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is
unknown, enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g.,
Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Influenza VaccinationInitial Entry
5. Date:
Date Location User Value Reason
Nov-11-2020 16:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae4091\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0940823
Page 208 of 233
***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: 11411221 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to For
…[truncated]