125742 S1 M5 CRF c4591001 1007 10071306

Document text

Page 1 of 459
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131664
Page 2 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/12/2020
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131665
Page 3 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071306]
2.Birth Date: /1962
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:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131666
Page 4 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131667
Page 5 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131668
Page 6 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131669
Page 7 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Salpingo-oophorectomy unilateral]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Asthma]
Start Date: Jan/6/2020
Ongoing: YES
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131670
Page 8 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Obesity]
Start Date: UNK/UNK/2003
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal allergy]
Start Date: UNK/UNK/1992
Ongoing: YES
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131671
Page 9 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE Comments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131672
Page 10 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
2.Weight: [93.3]
3.Unit: kg
4.Height: [170.2]
5.Unit: cm
6.Body Mass Index: [32.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131673
Page 11 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131674
Page 12 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/12/2020
2.Randomization Number: [268640]
3.Randomization Group: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131675
Page 13 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYTYV]
5.bSample ID [BMPSMM]
5.cSample ID [BMPSMN]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131676
Page 14 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYTYN]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131677
Page 15 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/12/2020 15:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131678
Page 16 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131679
Page 17 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131680
Page 18 of 459
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131681
Page 19 of 459
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131682
Page 20 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
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 [BPYV99]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131683
Page 21 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/2/2020 13:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131684
Page 22 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131685
Page 23 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
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 [BP90F8]
5.bSample ID [BMRW8D]
5.cSample ID [BMRW8J]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131686
Page 24 of 459
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131687
Page 25 of 459
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131688
Page 26 of 459
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131689
Page 27 of 459
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131690
Page 28 of 459
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131691
Page 29 of 459
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131692
Page 30 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131693
Page 31 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/1/2021
2.Date of First Symptom
Started:Dec/31/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/16/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131694
Page 32 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [chest tightness]
5.bSymptoms - Other Text: [fatigue]
5.cSymptoms - Other Text: [headache]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131695
Page 33 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jan/3/2
021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131696
Page 34 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/3/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection
Location:NASOPHARYNX Comments
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings
/Details:[ ] Comments
9.Trade Name Other, Specify: [CLIA certified lab] Comments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131697
Page 35 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/1/2021
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 [RW86896]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131698
Page 36 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:[subject did not come in]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131699
Page 37 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131700
Page 38 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?YES
Has the subject been in intensive care due to potential
COVID-19 illness?
NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131701
Page 39 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Hospitalization Catego
ryHospitalization
TermAdmission
DateOngoing Form Instance
 1.HOSPITALIZATION ST
ATUS HOSPITAL   Jan/11/2021  NO
Discharge D
ate:
Jan/12/202
1
 Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131702
Page 40 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/11/2021
4.Ongoing? NO
Discharge Date:
Jan/12/2021
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131703
Page 41 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131704
Page 42 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131705
Page 43 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
Jan/3/2021
3.Toxicity Grade: 2
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131706
Page 44 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131707
Page 45 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131708
Page 46 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
y for La
b TestVendor NameColle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
 1.CLINIC
AL CHE
MISTRY
 TriHealth Laboratory
10500 Montgomery
Road,Cincinnati,OH
45242 Jan/1
1/202
1 BLO
OD Sponsor
-Defined
Identifie
rTest:Re
sul
t:
329  C Reactive
Protein_P
X329 16
0 
30  Alanine A
minotransf
erase_PX3
0 16 
28  Aspartate
Aminotran
sferase_P
X28 [ ] 
35  Alkaline P
hosphatase
_PX35 48 
21  Bilirubin_
PX21 .6 
47  Blood Ure
a Nitrogen
_PX47 14 
48  Creatinine
_PX48 .69
 Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131709
Page 47 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category
for Lab
TestVendor NameCollec
tion D
ate:Speci
men
TypeLab ResultForm Insta
nce
 2.CLINICA
L CHEM
ISTRY TriHealth Labora
tory
10500 Montgom
ery Road, Cincin
nati, OH 45242 Jan/12
/2021 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive
Protein_PX
329 [ ] 
30  Alanine Am
inotransfera
se_PX30 [ ] 
28  Aspartate A
minotransfe
rase_PX28 [ ] 
35  Alkaline Ph
osphatase_P
X35 [ ] 
21  Bilirubin_P
X21 [ ] 
47  Blood Urea
Nitrogen_P
X47 19 
48  Creatinine_
PX48 .62
 Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131710
Page 48 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[TriHealth Laboratory 10500 Montgomery Road,Cincinnati,OH
45242]
3.Collection Date: Jan/11/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [160]
Not Done:
LNMT Low
[0]
High
[4.9]
Unit
mg/L
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131711
Page 49 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [16]
Not Done:
LNMT Low
[10]
High
[60]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131712
Page 50 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [48]
Not Done:
LNMT Low
[35]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [.6]
Not Done:
LNMT Low
[0.0]
High
[1.2]
Unit
mg/dL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131713
Page 51 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [14]
Not Done:
LNMT Low
[8]
High
[26]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.69]
Not Done:
LNMT Low
[.60]
High
[1.20]
Unit
mg/dL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131714
Page 52 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[TriHealth Laboratory
10500 Montgomery Road, Cincinnati, OH 45242]
3.Collection Date: Jan/12/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131715
Page 53 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131716
Page 54 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131717
Page 55 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[8]
High
[26]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.62]
Not Done:
LNMT Low
[.6]
High
[1.2]
Unit
mg/dL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131718
Page 56 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
y for La
b TestVendor Name (DERI
VED)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
 1.HEMAT
OLOGY
 TriHealth Laboratory 1
0500 Montgomery Roa
d, Cincinnati,OH 4524
2 Jan/11
/2021 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
1  Hemogl
obin_P
X1 12.
4 
2  Hemato
crit_PX
2 37.
2 
3  Erythro
cytes_P
X3 4.3
1 
5  Platelet
s_PX5 31
9 
7  Leukoc
ytes_P
X7 5.3
 
608  Neutrop
hils_PX
608 81 
609  Eosinop
hils_PX
609 0 Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131719
Page 57 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
y for La
b TestVendor Name (DERI
VED)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
612  Monoc
ytes_P
X612 8 
610  Basophi
ls_PX6
10 0 
611  Lymph
ocytes_
PX611 11 
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131720
Page 58 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[TriHealth Laboratory 10500 Montgomery Road,
Cincinnati,OH 45242]
3.Collection Date: Jan/11/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.4]
Not Done:
LNMT Low
[12.0]
High
[15.2]
Unit
g/L
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131721
Page 59 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [37.2]
Not Done:
LNMT Low
[36]
High
[46]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.31]
Not Done:
LNMT Low
[3.0]
High
[5.2]
Unit
10^3/uL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131722
Page 60 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [319]
Not Done:
LNMT Low
[140]
High
[375]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.3]
Not Done:
LNMT Low
[3.6]
High
[5.2]
Unit
g/dL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131723
Page 61 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [81]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[.03]
High
[.45]
Unit
10^3/uL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131724
Page 62 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [8]
Not Done:
LNMT Low
[.20]
High
[.90]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[.00]
High
[.20]
Unit
10^3/uL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131725
Page 63 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [11]
Not Done:
LNMT Low
[1.00]
High
[4.00]
Unit
10^3/uL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131726
FDA-CBER-2021-5683-0131727
FDA-CBER-2021-5683-0131728
Page 66 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/11/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [134]
Diastolic: [70]
Respiratory Rate in
respirations/minute:[24]
Heart Rate in
beats/minute:[104]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131729
Page 67 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/12/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [68]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in
beats/minute:[87]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131730
FDA-CBER-2021-5683-0131731
FDA-CBER-2021-5683-0131732
Page 70 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/11/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131733
Page 71 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/12/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131734
Page 72 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131735
Page 73 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131736
Page 74 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131737
Page 75 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131738
Page 76 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of As
sessmentLocation of
AssessmentImaging
MethodOverall AssessmentForm Instan
ce
 1.Jan/11/202
1 CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
Patchy left bibasilar airspace dise
ase consistent with pneumonia
 Repeating
Pages
 2.Jan/11/202
1 CHEST  CT SCA
N NORMAL  Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131739
Page 77 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/11/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Patchy left bibasilar airspace disease consistent with
pneumonia]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131740
Page 78 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/11/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131741
Page 79 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131742
Page 80 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/23/2021
2.Date of First Symptom
Started:Feb/19/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131743
Page 81 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131744
Page 82 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131745
Page 83 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131746
Page 84 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[participant did not have kit and was not interested in
completing another nasal swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131747
Page 85 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:[subject did not come in]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131748
Page 86 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131749
Page 87 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131750
FDA-CBER-2021-5683-0131751
Page 89 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Hospitalization Details
1.Hospitalization Category:
2.Hospitalization Term:
3.Admission Date: //
4.Ongoing?
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Page 90 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131753
Page 91 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
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FDA-CBER-2021-5683-0131754
Page 92 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Queries
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?NO
3.Toxicity Grade: 2
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131755
Page 93 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131756
Page 94 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131757
Page 95 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.  [ ]     Sponsor-Defin
ed IdentifierTe
st:Res
ult:
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131758
Page 96 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.aSponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131759
Page 97 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.  [ ]     Sponsor-Defi
ned Identifie
rTe
st:Res
ult:
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] 
[ ]   [ ] Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131760
Page 98 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.aSponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131761
FDA-CBER-2021-5683-0131762
Page 100 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131763
FDA-CBER-2021-5683-0131764
Page 102 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131765
Page 103 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131766
Page 104 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131767
Page 105 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131768
Page 106 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
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Page 107 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131770
Page 108 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131771
Page 109 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131772
Page 110 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
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 [BRB91N]
5.bSample ID [BNWMX0]
5.cSample ID [BNWMX2]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131773
Page 111 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131774
Page 112 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131775
Page 113 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  left lower lobe
pneumonia Feb/23/2021
UNK:UNK YES  Repeating
Pages
 2.ADVERSE
EVENT 2  sepsis  Feb/23/2021
UNK:UNK YES  Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131776
Page 114 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[left lower lobe pneumonia]
4.Start Date Time: Feb/23/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131777
Page 115 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Legionella bacteria]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131778
Page 116 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131779
Page 117 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[sepsis]
4.Start Date Time: Feb/23/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131780
Page 118 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Legionella bacteria]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131781
Page 119 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131782
Page 120 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131783
Page 121 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131784
Page 122 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131785
Page 123 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131786
Page 124 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131787
Page 125 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131788
Page 126 of 459
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131789
Page 127 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131790
FDA-CBER-2021-5683-0131791
Page 129 of 459
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131792
Page 130 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131793
Page 131 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131794
Page 132 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131795
Page 133 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131796
Page 134 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131797
Page 135 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131798
Page 136 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131799
Page 137 of 459
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131800
Page 138 of 459
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131801
Page 139 of 459
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131802
Page 140 of 459
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131803
Page 141 of 459
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131804
Page 142 of 459
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131805
Page 143 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131806
Page 144 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131807
Page 145 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131808
Page 146 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131809
Page 147 of 459
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131810
Page 148 of 459
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131811
Page 149 of 459
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131812
Page 150 of 459
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131813
Page 151 of 459
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131814
Page 152 of 459
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131815
Page 153 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/30/2020
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131816
Page 154 of 459
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131817
Page 155 of 459
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131818
Page 156 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-12-2020 14:22:04 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131819
Page 157 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - Comments
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-14-2020 13:43:17 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
FormOct-12-2020 15:38:55 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-14-2020 13:43:17 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
1Oct-12-2020 15:38:55 (UTC-05:00)
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Oct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Oct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aOct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aOct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aOct-12-2020 15:37:28 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormNov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Nov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 170 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Nov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 171 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Nov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 172 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Nov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 173 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Nov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 174 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aNov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aNov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aNov-02-2020 14:46:27 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 177 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
FormJan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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Page 178 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
1Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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Page 179 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
2Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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Page 180 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
3Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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Page 181 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
4Jan-05-2021 16:37:35 (UTC-05:00)
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Page 182 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
5Jan-05-2021 16:37:35 (UTC-05:00)
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Page 183 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
6Jan-05-2021 16:37:35 (UTC-05:00)
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FDA-CBER-2021-5683-0131846
Page 184 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
7Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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FDA-CBER-2021-5683-0131847
Page 185 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
8Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131848
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Jan-12-2021 15:06:59 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)
9Jan-05-2021 16:37:35 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
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090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131849
Page 187 of 459
***Confidential***
Header Text: c4591001
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131850
Page 188 of 459
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Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131851
Page 189 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131852
Page 190 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131853
Page 191 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131854
Page 192 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131855
Page 193 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131856
Page 194 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131857
Page 195 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131858
Page 196 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Feb-23-2021 14:11:09 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131859
Page 197 of 459
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Laura Pace  N/A Mar-11-2021 10:46:24 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Mar-08-2021 23:04:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
Laura Pace  N/A Feb-22-2021 22:05:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131860
Page 198 of 459
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
N/A
Robert
Frenck Approved Feb-15-2021 22:58:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
Laura Pace  N/A Feb-12-2021 11:31:04 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Feb-07-2021 22:59:41 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131861
Page 199 of 459
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
Laura Pace  N/A Jan-31-2021 19:48:28 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-29-2021 22:59:15 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131862
Page 200 of 459
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
Laura Pace  N/A Jan-26-2021 15:03:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-23-2021 17:19:44 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131863
Page 201 of 459
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131864
Page 202 of 459
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-12-2020
14:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-12-2020
14:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131865
Page 203 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-12-2020
14:21:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/12/2020Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131866
Page 204 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-12-2020
14:20:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10071306Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-12-2020
14:20:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1962Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-12-2020
14:21:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131867
Page 205 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-12-2020
14:21:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-12-2020
14:21:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131868
Page 206 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020
14:21:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/12/2020Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131869
Page 207 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-12-2020
15:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020
15:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
15:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131870
Page 208 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-12-2020
15:39:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Hysterecto
my
Start Date
:UNK/UN
K/2003
Ongoing: NO
End Date
:
UNK/U
NK/200
3Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-12-2020
15:39:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131871
Page 209 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020
15:39:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
HysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-12-2020
15:39:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2003Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-12-2020
15:39:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.b
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131872
Page 210 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020
08:54:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Line/M
H Num
ber:2
Medica
l Histor
y Term
:Salpingo-oo
phorectomy
unilateral
Start D
ate:UNK/UNK/
2003
Ongoin
g:NO
End Date:
UNK/UN
K/2003Changed
Information
Oct-12-2020
15:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History
Term:Salpingo-o
ophorecto
my
Start Da
te:UNK/UN
K/2003
Ongoing
:NO
End Date
:
UNK/U
NK/200
3Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131873
Page 211 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Oct-12-2020
15:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020
19:41:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Lingyan
Zuo
(pfe.zuol02)Query 1: Closed Response
satisfies query
Oct-14-2020
08:54:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-14-2020
08:54:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Salpingo-oophorect
omy unilateralChanged
Information
Oct-13-2020
21:57:24
(UTC-05:00)ACV0PFEINFP6000  Lingyan
Zuo
(pfe.zuol02)Query 1: Opened ClinQuery:
Please can you
update to
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131874
Page 212 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)specify whether
the Salpingo-
oophorectomy
is bilateral or
unilateral?
Thanks
Oct-12-2020
15:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Salpingo-oophorect
omyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-12-2020
15:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-12-2020
15:40:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.c
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131875
Page 213 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-12-2021
15:16:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Asthm
a
Start Date: Jan/6/
2020
Ongoing: YESChanged
Information
Oct-12-2020
15:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term
:Asthma
Start Date: Mar/UN
K/2020
Ongoing: YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131876
Page 214 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Oct-12-2020
15:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020
15:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Mar-12-2021
15:16:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Jan/6/2020Changed
Information
Oct-12-2020
15:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Mar/UNK/2020Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131877
Page 215 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Ongoing:
Date Location User Value Reason
Oct-12-2020
15:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-12-2020
15:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Obesity
Start Date: UNK/U
NK/200
3
Ongoing: YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131878
Page 216 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Oct-12-2020
15:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020
15:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ObesityInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-12-2020
15:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2003Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131879
Page 217 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-12-2020
15:40:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-12-2020
15:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Seasonal
allergy
Start Date: UNK/U
NK/199
2
Ongoing: YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131880
Page 218 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Oct-12-2020
15:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020
15:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Seasonal allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-12-2020
15:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1992Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131881
Page 219 of 459
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-12-2020
15:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131882
Page 220 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-15-2020
20:45:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Closed Response
satisfies query
Oct-14-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-14-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
The subject is NOT
known to be HIV PO
SITIVEInitial Entry
Oct-14-2020
13:43:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Oct-13-2020
20:47:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Opened ClinQuery:
Please confirm
why the HIV
status has been
answered Not
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131883
Page 221 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
applicable and
not either a
Yes or No?
Oct-12-2020
15:38:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131884
Page 222 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
93.3Initial Entry
3. Unit:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131885
Page 223 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
170.2Initial Entry
5. Unit:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.2Initial Entry
7.a
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Ide 1Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131886
Page 224 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.1
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131887
Page 225 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-12-2020
15:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131888
Page 226 of 459
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131889
Page 227 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Defi
ned Identifie
r:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
eInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131890
Page 228 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done:: Not Ap
plicabl
e
6.a Sponsor ID:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131891
Page 229 of 459
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Not Done:
Date Location User Value Reason
Oct-12-2020
15:37:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131892
Page 230 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-12-2020
15:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-12-2020
15:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
268640Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131893
Page 231 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
15:36:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
15:36:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
15:41:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
15:36:24ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131894
Page 232 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
15:36:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
15:41:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYTY
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
15:41:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTYVInitial Entry
5.b
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131895
Page 233 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-12-2020
15:41:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMPSM
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
15:41:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSMMInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020
15:41:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMPSM
NInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131896
Page 234 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
15:41:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSMNInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131897
Page 235 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
15:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
15:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
15:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
15:36:32ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131898
Page 236 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
15:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Oct-14-2020
01:43:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response
satisfies query
Oct-13-2020
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dChanged
Information
Oct-13-2020
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse LePage
(pfe.jlepage)Data Entry: Changed
Information
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131899
Page 237 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-13-2020
13:23:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM: A
carriage is
identified. To
avoid
processing
errors, please
remove the
identified
character by
deleting the
entry and
re-entering the
data (without
using copy
and paste).
Oct-12-2020
15:46:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse LePage
(pfe.jlepage)Data Entry: Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
15:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYTY
NInitial Entry
5.a Sample ID
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131900
Page 238 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-12-2020
15:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTYNInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131901
Page 239 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131902
Page 240 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/12/2020 15:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131903
Page 241 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-12-2020
16:06:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131904
Page 242 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-12-2020
16:07:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO - REACTOGENIC
ITY E-DIARY NOT C
OLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131905
Page 243 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020
14:45:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Nov/2/2020Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131906
Page 244 of 459
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Nov/2/2020Initial Entry
2.a
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.6
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131907
Page 245 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-02-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131908
Page 246 of 459
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131909
Page 247 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Defi
ned Identifie
r:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
eInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131910
Page 248 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done:: Not Ap
plicabl
e
6.a Sponsor ID:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131911
Page 249 of 459
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Not Done:
Date Location User Value Reason
Nov-02-2020
14:46:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131912
Page 250 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020
14:14:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020
14:14:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
14:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-02-2020
14:14:33ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131913
Page 251 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-02-2020
14:14:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020
14:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYV9
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020
14:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV99Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131914
Page 252 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131915
Page 253 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Nov/2/2020 13:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131916
Page 254 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-02-2020
14:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131917
Page 255 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020
14:42:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Nov/30/2020Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131918
Page 256 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-30-2020
16:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-30-2020
14:42:41ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131919
Page 257 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-30-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Nov/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-30-2020
16:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP90F8Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-30-2020
16:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP90F8Initial Entry
5.b
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131920
Page 258 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-30-2020
16:37:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMRW8
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-30-2020
16:37:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMRW8DInitial Entry
5.c
Date Location User Value Reason
Nov-30-2020
16:37:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMRW8
JInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131921
Page 259 of 459
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Nov-30-2020
16:37:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMRW8JInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131922
Page 260 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021
02:08:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Vikas Joshi
(pfe.joshiv22)Query 4: Closed Response
satisfies query
Jan-06-2021
00:03:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe.mahadp07)Query 3: Closed Closed as data
entered.
Jan-05-2021
16:39:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 4: Answere
dcompleted
Jan-05-2021
16:38:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 3: Answere
dcompleted
Jan-05-2021
16:36:58
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131923
Page 261 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada)
Jan-05-2021
06:12:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Rajashekhar
Reddy
(pfe.reddyr51)Query 4: Opened DM: Kindly
review and
complete
‘Health Care
Utilization,
Microbiology
Specimen,
Illness Details
form' at this
visit. Thank
you.
Jan-05-2021
04:23:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Bembem
Takhellambam
(pfe.takheb)Query 3: Opened DM: Date of
Visit is
completed but
Nasal Swab
(SWAB PFE)
CRF is not
initiated.
Please review
and update the
data as
appropriate.
Thanks
Jan-05-2021
01:19:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Sonal K
(pfe.ks66)Query 2: Opened Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131924
Page 262 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
missing. Please
review and
update as
appropriate.
Jan-04-2021
09:45:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-04-2021
09:45:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing. Please
review and
update as
appropriate.
Jan-04-2021
09:45:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131925
Page 263 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-04-2021
09:45:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Jesse LePage
(pfe.jlepage)Data Entry:
Jan/1/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-04-2021
09:45:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131926
Page 264 of 459
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-05-2021
16:36:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Jan/1/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-05-2021
16:36:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/31/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-26-2021
15:03:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
Date of Last Sympto
m Resolved:
Jan/16/2021New
Information
Jan-05-2021 ACV0PFEINFP6000  Laura Data Entry: Initial Entry
090177e196ae4022\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131927
Page 265 of 459
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071306 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
16:36:58
(UTC-05:00)
Eastern Time (US
& Canada)Pace
(pfe.lpace)YES
4.a
Date Location User Value Reason
Jan-05-2021
16:36:5
…[truncated]