Document text
Page 1 of 297
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130507
Page 2 of 297
***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: 10071124 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
Aug/5/2020
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130508
Page 3 of 297
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071124]
2.Birth Date: /1951
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:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130509
Page 4 of 297
***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: 10071124 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 Aug/5/2020
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130510
Page 5 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130511
Page 6 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130512
Page 7 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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:[Drug allergy pencillin]
Start Date: UNK/UNK/1963
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal allergy]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Breast cancer stage I]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130513
Page 8 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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:[Lumpectomy (breast cancer)]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130514
Page 9 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [67.0]
3.Unit: kg
4.Height: [163.2]
5.Unit: cm
6.Body Mass Index: [25.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130515
Page 10 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130516
Page 11 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222690]
3.Randomization Group: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130517
Page 12 of 297
***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: 10071124 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:
Aug/5/2020
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 [BM89GZ]
5.bSample ID [BM89H0]
5.cSample ID [BM89H1]
5.dSample ID [BPFZZ0]
5.eSample ID [BPFZZ1]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130518
Page 13 of 297
***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: 10071124 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:
Aug/5/2020
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 [BM89F3]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130519
Page 14 of 297
***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: 10071124 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: Aug/5/2020 11:14
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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130520
Page 15 of 297
***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: 10071124 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
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130521
Page 16 of 297
***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: 10071124 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 Aug/26/2020
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130522
Page 17 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130523
Page 18 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130524
Page 19 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130525
Page 20 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130526
Page 21 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130527
Page 22 of 297
***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: 10071124 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:
Aug/26/2020
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 [BP75G9]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130528
Page 23 of 297
***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: 10071124 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: Aug/26/2020 12:16
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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130529
Page 24 of 297
***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: 10071124 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 Sep/23/2020
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130530
Page 25 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130531
Page 26 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130532
Page 27 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130533
Page 28 of 297
***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: 10071124 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:
Sep/23/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYTSS]
5.bSample ID [BMPSBH]
5.cSample ID [BMPSBJ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130534
Page 29 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130535
Page 30 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130536
Page 31 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130537
Page 32 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130538
Page 33 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130539
Page 34 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130540
Page 35 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130541
Page 36 of 297
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130542
Page 37 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130543
Page 38 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130544
Page 39 of 297
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130545
Page 40 of 297
***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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130546
Page 41 of 297
***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: 10071124 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:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130547
Page 42 of 297
***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: 10071124 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 [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130548
Page 43 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 generalized m
yalgia Feb/9/2021 1
8:00 NO
End Date Time:
Feb/10/2021 18:0
0
Repeating
Pages
2.ADVERSE
EVENT 2 chills Feb/9/2021 1
8:00 NO
End Date Time:
Feb/10/2021 18:0
0
Repeating
Pages
3.ADVERSE
EVENT 3 axillary lymph
adenopathy Feb/10/2021
UNK:UNK NO
End Date Time:
Feb/12/2021 UNK
:UNK
Repeating
Pages
4.ADVERSE
EVENT 4 headache Feb/9/2021 1
8:00 NO
End Date Time:
Feb/10/2021 18:0
0
Repeating
Pages
5.ADVERSE
EVENT 5 injection site p
ain Feb/10/2021
UNK:UNK NO
End Date Time:
Feb/11/2021 UNKRepeating
Pages
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130549
Page 44 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
:UNK
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130550
Page 45 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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)[generalized myalgia]
4.Start Date Time: Feb/9/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 18:00
6.Toxicity Grade: 1
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130551
Page 46 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130552
Page 47 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130553
Page 48 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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)[chills]
4.Start Date Time: Feb/9/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 18:00
6.Toxicity Grade: 1
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130554
Page 49 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130555
Page 50 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130556
Page 51 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[axillary lymphadenopathy]
4.Start Date Time: Feb/10/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130557
Page 52 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130558
Page 53 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130559
Page 54 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[headache]
4.Start Date Time: Feb/9/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 18:00
6.Toxicity Grade: 2
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130560
Page 55 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130561
Page 56 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130562
Page 57 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[injection site pain]
4.Start Date Time: Feb/10/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 1
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
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Page 60 of 297
***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: 10071124 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
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***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: 10071124 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[ ]
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Page 62 of 297
***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: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130568
Page 63 of 297
***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: 10071124 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: //
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Page 64 of 297
***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: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130570
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***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: 10071124 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?
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Page 66 of 297
***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: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130572
Page 67 of 297
***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: 10071124 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?
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130573
FDA-CBER-2021-5683-0130574
Page 69 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
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FDA-CBER-2021-5683-0130575
Page 70 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130576
Page 71 of 297
***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: 10071124 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:
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FDA-CBER-2021-5683-0130577
Page 72 of 297
***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: 10071124 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:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
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Page 73 of 297
***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: 10071124 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?
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130579
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***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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130580
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***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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130581
Page 76 of 297
***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: 10071124 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/13/2021
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130582
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***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130583
Page 78 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130584
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***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130585
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***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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130586
Page 81 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10071124 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/19/2021
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130587
Page 82 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130588
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***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130589
Page 84 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130590
Page 85 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130591
Page 86 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10071124 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:
Jan/19/2021
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 [BRB8NB]
5.bSample ID [BNWMN8]
5.cSample ID [BNWMNC]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130592
Page 87 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10071124 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:
Jan/19/2021
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 [BRB8N9]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130593
Page 88 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 10:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130594
Page 89 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10071124 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/9/2021
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130595
Page 90 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130596
Page 91 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10071124 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:
Feb/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRB94Y]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130597
Page 92 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 13:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130598
Page 93 of 297
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Mar/9/2021
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130599
Page 94 of 297
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/9/2021
3.Comments: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130600
Page 95 of 297
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130601
Page 96 of 297
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130602
Page 97 of 297
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130603
Page 98 of 297
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 10071124 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: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130604
Page 99 of 297
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 :Mar/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130605
Page 100 of 297
***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: 10071124 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 Sep/23/2020
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130606
Page 101 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130607
Page 102 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-10-2021 13:35:35 (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.
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130608
Page 103 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-05-2020 11:45:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130609
Page 104 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130610
Page 105 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130611
Page 106 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130612
Page 107 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130613
Page 108 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130614
Page 109 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130615
Page 110 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130616
Page 111 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130617
Page 112 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-05-2020 11:46:46 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130618
Page 113 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130619
Page 114 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130620
Page 115 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130621
Page 116 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130622
Page 117 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130623
Page 118 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130624
Page 119 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130625
Page 120 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130626
Page 121 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-26-2020 12:07:43 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130627
Page 122 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-19-2021 11:24:05 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130628
Page 123 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130629
Page 124 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130630
Page 125 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Jan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130631
Page 126 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Jan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130632
Page 127 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Jan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130633
Page 128 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Jan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130634
Page 129 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130635
Page 130 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130636
Page 131 of 297
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJan-19-2021 11:24:33 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130637
Page 132 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130638
Page 133 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Feb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130639
Page 134 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Feb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130640
Page 135 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Feb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130641
Page 136 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Feb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130642
Page 137 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Feb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130643
Page 138 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130644
Page 139 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130645
Page 140 of 297
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:11:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130646
Page 141 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-10-2021 13:35:35 (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 Mar-10-2021 09:26:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Mar-08-2021 08:57:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130647
Page 142 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Feb-21-2021 11:26:31 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Feb-15-2021 22:14:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130648
Page 143 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Feb-09-2021 13:11:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-23-2021 17:08:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130649
Page 144 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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-19-2021 09:49:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-23-2020 22:05:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130650
Page 145 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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 Sep-23-2020 11:10:59 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-10-2020 14:55:44 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130651
Page 146 of 297
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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.
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130652
Page 147 of 297
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-05-2020
11:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-05-2020
11:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130653
Page 148 of 297
***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: 10071124 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
Aug-05-2020
11:45:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/5/2020Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130654
Page 149 of 297
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-05-2020
11:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071124Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020
11:44:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1951Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020
11:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130655
Page 150 of 297
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:45:24
(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
Aug-05-2020
11:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130656
Page 151 of 297
***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: 10071124 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
Aug-05-2020
11:45:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/5/2020Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130657
Page 152 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-05-2020
11:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020
11:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020
11:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130658
Page 153 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-05-2020
11:48:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Drug aller
gy pencill
in
Start Date
:UNK/UN
K/1963
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-05-2020
11:48:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-05-2020
11:48:44
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Drug allergy pencillinInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130659
Page 154 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-05-2020
11:48:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1963Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-05-2020
11:48:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-05-2020
11:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Seasonal
allergyInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130660
Page 155 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: UNK/U
NK/200
0
Ongoing: YES
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130661
Page 156 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Aug-05-2020
11:49:01
(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
Aug-05-2020
11:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Seasonal allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-05-2020
11:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130662
Page 157 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-05-2020
11:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Breast can
cer stage I
Start Date
:UNK/UN
K/1993
Ongoing: NO
End Date
:
UNK/U
NK/199
8Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130663
Page 158 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Aug-05-2020
11:49:38
(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
Aug-05-2020
11:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Breast cancer stage IInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-05-2020
11:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1993Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130664
Page 159 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.d
Date Location User Value Reason
Aug-05-2020
11:50:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:4
Medical
History
Term:Lumpectom
y (breast can
cer)
Start Da
te:UNK/UNK/
1993
Ongoing
:NO
End Date:
UNK/UN
K/1993Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130665
Page 160 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-05-2020
11:50:03
(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
Aug-05-2020
11:50:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Lumpectomy (breast c
ancer)Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-05-2020
11:50:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1993Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130666
Page 161 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:50:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130667
Page 162 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
67.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130668
Page 163 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
163.2Initial Entry
5. Unit:
Date Location User Value Reason
Aug-05-2020
11:47:27
(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
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.2Initial Entry
7.a
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide 1Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130669
Page 164 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.6
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130670
Page 165 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:47:27
(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
Aug-05-2020
11:47:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130671
Page 166 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-05-2020
11:46:46
(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
Aug-05-2020
11:46:46
(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
Aug-05-2020
11:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130672
Page 167 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-05-2020
11:46:46
(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
Aug-05-2020
11:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-05-2020
11:46:46
(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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130673
Page 168 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-05-2020
11:46:46
(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
Aug-05-2020
11:46:46
(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
Aug-05-2020
11:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130674
Page 169 of 297
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Not Done:
Date Location User Value Reason
Aug-05-2020
11:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130675
Page 170 of 297
***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: 10071124 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
Aug-05-2020
11:50:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-05-2020
11:50:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
222690Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130676
Page 171 of 297
***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: 10071124 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
Aug-05-2020
11:46:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020
11:46:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020
16:57:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-05-2020
11:46:31ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130677
Page 172 of 297
***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: 10071124 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.
Aug-05-2020
11:46:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020
16:57:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89G
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020
16:57:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89GZInitial Entry
5.b
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130678
Page 173 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-05-2020
16:58:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89H
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020
16:58:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89H0Initial Entry
5.c
Date Location User Value Reason
Aug-05-2020
16:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89H
1Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130679
Page 174 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Aug-05-2020
16:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89H1Initial Entry
5.d
Date Location User Value Reason
Aug-05-2020
16:58:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPFZZ
0Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020
16:58:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZZ0Initial Entry
5.e
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130680
Page 175 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
16:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPFZZ
1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020
16:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZZ1Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130681
Page 176 of 297
***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: 10071124 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
Aug-05-2020
11:46:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020
11:46:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020
16:57:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-05-2020
11:46:38ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130682
Page 177 of 297
***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: 10071124 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.
Aug-05-2020
11:46:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020
16:57:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89F
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020
16:57:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89F3Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130683
Page 178 of 297
***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: 10071124 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
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130684
Page 179 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/5/2020 11:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130685
Page 180 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-05-2020
11:58:05
(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
Aug-05-2020
11:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130686
Page 181 of 297
***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: 10071124 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
Aug-05-2020
11:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130687
Page 182 of 297
***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: 10071124 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
Aug-26-2020
12:07:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130688
Page 183 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130689
Page 184 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130690
Page 185 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130691
Page 186 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-26-2020
12:09:20ACV0PFEINFP6000 Laura
PaceData Entry:
Symptom:: CInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130692
Page 187 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.lpace) HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130693
Page 188 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130694
Page 189 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130695
Page 190 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130696
Page 191 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130697
Page 192 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130698
Page 193 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130699
Page 194 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130700
Page 195 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130701
Page 196 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130702
Page 197 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020
12:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130703
Page 198 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020
12:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
2.a
Date Location User Value Reason
Aug-26-2020
12:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-26-2020
12:08:16
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130704
Page 199 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-26-2020
12:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-26-2020
12:08:16
(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
Aug-26-2020
12:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130705
Page 200 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-26-2020
12:07:43
(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
Aug-26-2020
12:07:43
(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
Aug-26-2020
12:07:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130706
Page 201 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-26-2020
12:07:43
(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
Aug-26-2020
12:07:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020
12:07:43
(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
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130707
Page 202 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Aug-26-2020
12:07:43
(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
Aug-26-2020
12:07:43
(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
Aug-26-2020
12:07:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130708
Page 203 of 297
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Not Done:
Date Location User Value Reason
Aug-26-2020
12:07:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130709
Page 204 of 297
***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: 10071124 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
Aug-26-2020
12:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
12:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
13:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2020
12:07:55ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130710
Page 205 of 297
***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: 10071124 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.
Aug-26-2020
12:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
13:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BP75G
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
13:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP75G9Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130711
Page 206 of 297
***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: 10071124 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
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130712
Page 207 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020 12:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130713
Page 208 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020
16:44:42
(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
Aug-26-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130714
Page 209 of 297
***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: 10071124 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
Sep-23-2020
11:10:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/23/2020Initial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130715
Page 210 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130716
Page 211 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130717
Page 212 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130718
Page 213 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-23-2020
11:12:01ACV0PFEINFP6000 Laura
PaceData Entry:
Symptom:: CInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130719
Page 214 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.lpace) HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130720
Page 215 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130721
Page 216 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130722
Page 217 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130723
Page 218 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130724
Page 219 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130725
Page 220 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130726
Page 221 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130727
Page 222 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130728
Page 223 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130729
Page 224 of 297
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020
11:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130730
Page 225 of 297
***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: 10071124 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
Sep-23-2020
11:11:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
11:11:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
11:42:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-23-2020
11:11:21ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130731
Page 226 of 297
***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: 10071124 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.
Sep-23-2020
11:11:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
11:42:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYTS
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
11:42:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTSSInitial Entry
5.b
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130732
Page 227 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-23-2020
11:42:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMPSB
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020
11:42:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSBHInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020
11:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BMPSB
JInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130733
Page 228 of 297
***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: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Sep-23-2020
11:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSBJInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130734
Page 229 of 297
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 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
Sep-23-2020
11:12:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020
11:12:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020
11:12:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130735
Page 230 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130736
Page 231 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-14-2021
20:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130737
Page 232 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-14-2021
20:54:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130738
Page 233 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-14-2021
20:55:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130739
Page 234 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-14-2021
20:57:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130740
Page 235 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
generalized myalgiaInitial Entry
4. Start Date Time:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130741
Page 236 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/9/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Feb/10/2021 18:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130742
Page 237 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130743
Page 238 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOL
VEDInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130744
Page 239 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-14-2021
20:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130745
Page 240 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071124 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Feb-14-2021
20:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-14-2021
20:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-14-2021
20:50:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
chillsInitial Entry
4. Start Date Time:
090177e196ae402b\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130746
Page 241 of 297
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data
…[truncated]