Document text
Page 1 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130804
Page 2 of 178
***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: 10071159 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/10/2020
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130805
Page 3 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071159]
2.Birth Date: /1971
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130806
Page 4 of 178
***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: 10071159 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/10/2020
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130807
Page 5 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130808
Page 6 of 178
***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: 10071159 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/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130809
Page 7 of 178
***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: 10071159 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:[Allergy codeine]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Headache]
Start Date: UNK/UNK/1985
Ongoing: YES
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130810
Page 8 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/10/2020
2.Weight: [125.3]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [46.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130811
Page 9 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130812
Page 10 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/10/2020
2.Randomization Number: [45643]
3.Randomization Group: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130813
Page 11 of 178
***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: 10071159 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/10/2020
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 [BM812C]
5.bSample ID [BM812D]
5.cSample ID [BM812F]
5.dSample ID [BPG03J]
5.eSample ID [BPG03K]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130814
Page 12 of 178
***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: 10071159 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/10/2020
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 [BM8124]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130815
Page 13 of 178
***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: 10071159 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/10/2020 14:50
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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130816
Page 14 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130817
Page 15 of 178
***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: 10071159 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/31/2020
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130818
Page 16 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130819
Page 17 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130820
Page 18 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130821
Page 19 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130822
Page 20 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130823
Page 21 of 178
***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: 10071159 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/31/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP75MB]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130824
Page 22 of 178
***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: 10071159 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/31/2020 11:23
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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130825
Page 23 of 178
***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: 10071159 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/28/2020
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130826
Page 24 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130827
Page 25 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130828
Page 26 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130829
Page 27 of 178
***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: 10071159 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/28/2020
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 [BPYTTR]
5.bSample ID [BMPSDC]
5.cSample ID [BMPSDD]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130830
Page 28 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130831
Page 29 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BR0ZYB]
5.bSample ID [BNWN4T]
5.cSample ID [BNWN4Y]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130832
Page 30 of 178
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130833
Page 31 of 178
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130834
Page 32 of 178
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130835
Page 33 of 178
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130836
Page 34 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130837
Page 35 of 178
***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: 10071159 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: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130838
Page 36 of 178
***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: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130839
Page 37 of 178
***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: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130840
Page 38 of 178
***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: 10071159 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?
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130841
Page 39 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130842
Page 40 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130843
Page 41 of 178
***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: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130844
Page 42 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130845
Page 43 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130846
Page 44 of 178
***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: 10071159 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130847
Page 45 of 178
***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: 10071159 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: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130848
Page 46 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130849
Page 47 of 178
***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: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130850
Page 48 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Left axilla enlarg
ed lymph node Aug/11/2020
UNK:UNK NO
End Date Time:
Aug/12/2020 UN
K:UNK
Repeating
Pages
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130851
Page 49 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Left axilla enlarged lymph node]
4.Start Date Time: Aug/11/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/12/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130852
Page 50 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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?YES
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130853
Page 51 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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[ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130854
Page 52 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130855
Page 53 of 178
***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: 10071159 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[ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130856
Page 54 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130857
Page 55 of 178
***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: 10071159 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: //
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130858
Page 56 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130859
Page 57 of 178
***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: 10071159 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?
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130860
Page 58 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130861
Page 59 of 178
***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: 10071159 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?
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130862
FDA-CBER-2021-5683-0130863
Page 61 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130864
Page 62 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130865
Page 63 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130866
Page 64 of 178
***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: 10071159 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:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130867
Page 65 of 178
***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: 10071159 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?
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130868
Page 66 of 178
***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: 10071159 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: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130869
Page 67 of 178
***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: 10071159 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: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130870
Page 68 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130871
Page 69 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130872
Page 70 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130873
Page 71 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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 [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130874
Page 72 of 178
***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: 10071159 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/16/2021
2.Erroneous Visit
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130875
Page 73 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130876
Page 74 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130877
Page 75 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130878
Page 76 of 178
***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: 10071159 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: [ ]
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130879
Page 77 of 178
***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: 10071159 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/28/2020
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130880
Page 78 of 178
***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: 10071159 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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130881
Page 79 of 178
***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: 10071159 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-08-2021 21:06:00 (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.
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130882
Page 80 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-10-2020 15:13:48 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130883
Page 81 of 178
***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: 10071159 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-08-2021 21:06:00 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Laura Pace N/A Feb-21-2021 16:19:32 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-29-2020 10:25:58 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130884
Page 82 of 178
***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: 10071159 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-28-2020 11:23:46 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-10-2020 15:11:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130885
Page 83 of 178
***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: 10071159 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.
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130886
Page 84 of 178
***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: 10071159 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-10-2020
13:53:25
(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-10-2020
13:53:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130887
Page 85 of 178
***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: 10071159 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-10-2020
13:53:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/10/2020Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130888
Page 86 of 178
***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: 10071159 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-10-2020
13:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071159Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020
13:53:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1971Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-10-2020
13:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130889
Page 87 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-10-2020
13:53:54
(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-10-2020
13:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
BLACK OR AFRICA
N AMERICANInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130890
Page 88 of 178
***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: 10071159 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-10-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130891
Page 89 of 178
***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: 10071159 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-10-2020
15:14:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020
15:14:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020
15:14:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130892
Page 90 of 178
***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: 10071159 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-10-2020
15:16:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Allergy
codeine
Start Date: UNK/U
NK/199
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020
15:16:30
(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-10-2020
15:16:30
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Allergy codeineInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130893
Page 91 of 178
***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: 10071159 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-10-2020
15:16:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020
15:16:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-10-2020
15:16:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Headach
eInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130894
Page 92 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: UNK/U
NK/198
5
Ongoing: YES
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130895
Page 93 of 178
***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: 10071159 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-10-2020
15:16:50
(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-10-2020
15:16:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HeadacheInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-10-2020
15:16:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1985Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130896
Page 94 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-10-2020
15:16:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130897
Page 95 of 178
***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: 10071159 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-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
125.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130898
Page 96 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-10-2020
15:15:40
(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-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
46.0Initial Entry
7.a
Date Location User Value Reason
Aug-10-2020
15:15:40
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide 1Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130899
Page 97 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.5
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-10-2020
15:15:40
(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-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130900
Page 98 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-10-2020
15:15:40
(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-10-2020
15:15:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130901
Page 99 of 178
***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: 10071159 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-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130902
Page 100 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130903
Page 101 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-10-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130904
Page 102 of 178
***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: 10071159 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-10-2020
15:17:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-10-2020
15:17:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
45643Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130905
Page 103 of 178
***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: 10071159 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-10-2020
15:14:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
15:14:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020
17:34:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
15:14:24ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130906
Page 104 of 178
***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: 10071159 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-10-2020
15:14:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
17:34:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM812
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
17:34:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM812CInitial Entry
5.b
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130907
Page 105 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-10-2020
17:35:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM812
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020
17:35:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM812DInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020
17:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM812
FInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130908
Page 106 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Aug-10-2020
17:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM812FInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020
17:35:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG03JInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-10-2020
17:35:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG03JInitial Entry
5.e
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130909
Page 107 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-10-2020
17:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPG03
KInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020
17:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG03KInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130910
Page 108 of 178
***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: 10071159 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-10-2020
15:14:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
15:14:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020
17:34:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
15:14:32ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130911
Page 109 of 178
***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: 10071159 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-10-2020
15:14:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
17:34:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM812
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
17:34:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM8124Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130912
Page 110 of 178
***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: 10071159 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-10-2020
15:32:07
(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-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130913
Page 111 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/10/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-10-2020
15:32:07
(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-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130914
Page 112 of 178
***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: 10071159 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-10-2020
15:32:07
(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-10-2020
15:32:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130915
Page 113 of 178
***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: 10071159 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-10-2020
15:34:26
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130916
Page 114 of 178
***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: 10071159 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-31-2020
11:35:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/31/2020Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130917
Page 115 of 178
***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: 10071159 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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130918
Page 116 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130919
Page 117 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Symptom:
Date Location User Value Reason
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130920
Page 118 of 178
***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: 10071159 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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020
11:37:14ACV0PFEINFP6000 Laura
PaceData Entry:
Symptom:: CInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130921
Page 119 of 178
***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: 10071159 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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130922
Page 120 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130923
Page 121 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130924
Page 122 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130925
Page 123 of 178
***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: 10071159 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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130926
Page 124 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130927
Page 125 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(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-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130928
Page 126 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130929
Page 127 of 178
***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: 10071159 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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130930
Page 128 of 178
***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: 10071159 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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020
11:37:14
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130931
Page 129 of 178
***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: 10071159 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-31-2020
11:37:14
(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-31-2020
11:37:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130932
Page 130 of 178
***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: 10071159 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-31-2020
11:36:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020
11:36:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide
ntifier::1
Temperatur
e:37.0
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
11:36:04
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130933
Page 131 of 178
***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: 10071159 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-31-2020
11:36:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020
11:36:04
(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-31-2020
11:36:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130934
Page 132 of 178
***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: 10071159 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-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130935
Page 133 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130936
Page 134 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020
11:36:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130937
Page 135 of 178
***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: 10071159 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-31-2020
11:36:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
11:36:25
(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-31-2020
15:21:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
11:36:25ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130938
Page 136 of 178
***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: 10071159 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-31-2020
11:36:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
15:21:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BP75M
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
15:21:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP75MBInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130939
Page 137 of 178
***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: 10071159 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-31-2020
12:13:56
(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-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130940
Page 138 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/31/2020 11:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
12:13:56
(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-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130941
Page 139 of 178
***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: 10071159 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-31-2020
12:13:56
(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-31-2020
12:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130942
Page 140 of 178
***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: 10071159 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-28-2020
11:23:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/28/2020Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130943
Page 141 of 178
***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: 10071159 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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130944
Page 142 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130945
Page 143 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Symptom:
Date Location User Value Reason
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130946
Page 144 of 178
***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: 10071159 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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-28-2020
11:24:38ACV0PFEINFP6000 Laura
PaceData Entry:
Symptom:: CInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130947
Page 145 of 178
***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: 10071159 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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130948
Page 146 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130949
Page 147 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130950
Page 148 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130951
Page 149 of 178
***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: 10071159 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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130952
Page 150 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130953
Page 151 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(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-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130954
Page 152 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130955
Page 153 of 178
***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: 10071159 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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130956
Page 154 of 178
***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: 10071159 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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020
11:24:38
(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
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130957
Page 155 of 178
***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: 10071159 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-28-2020
11:24:38
(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-28-2020
11:24:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130958
Page 156 of 178
***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: 10071159 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-28-2020
11:23:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
11:23:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
13:35:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
11:23:59ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130959
Page 157 of 178
***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: 10071159 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-28-2020
11:23:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
13:35:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYTT
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
13:35:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTTRInitial Entry
5.b
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130960
Page 158 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-28-2020
13:35:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMPSD
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020
13:35:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSDCInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020
13:35:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMPSD
DInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130961
Page 159 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Sep-28-2020
13:35:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMPSDDInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130962
Page 160 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 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
Feb-23-2021
10:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/23/2021Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130963
Page 161 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 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
Feb-23-2021
10:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021
10:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021
10:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-23-2021
10:49:34ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130964
Page 162 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 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.
Feb-23-2021
10:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021
10:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BR0ZY
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-23-2021
10:52:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BR0ZYBInitial Entry
5.b
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130965
Page 163 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-23-2021
10:53:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BNWN
4TInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-23-2021
10:53:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BNWN4TInitial Entry
5.c
Date Location User Value Reason
Feb-23-2021
10:53:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BNWN
4YInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130966
Page 164 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Feb-23-2021
10:53:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BNWN4YInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130967
Page 165 of 178
***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: 10071159 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-28-2020
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130968
Page 166 of 178
***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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130969
Page 167 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-25-2020
11:50:10
(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
Aug-27-2020
04:36:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response
satisfies query
Aug-26-2020
10:10:32ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription
Error
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130970
Page 168 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-26-2020
10:10:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Left axilla enlarge
d lymph nodeTranscription
Error
Aug-26-2020
10:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 1: Opened DM: A trailing
space is
identified. To
avoid
processing
errors, please
remove the
identified
character by
deleting the
entry and
re-entering the
data (without
using copy and
paste).
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Left axilla enlarge
d lymph nodeInitial Entry
4. Start Date Time:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130971
Page 169 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/11/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Aug/12/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-25-2020
11:50:10
(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;
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130972
Page 170 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Aug-25-2020
11:50:10
(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
Aug-25-2020
11:50:10
(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
Aug-27-2020
13:11:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130973
Page 171 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-25-2020
11:50:10
(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
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-25-2020
11:50:10
(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
Aug-25-2020
11:50:10
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130974
Page 172 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-25-2020
11:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130975
Page 173 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 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
Feb-21-2021
16:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/16/2021Transcription
Error
Feb-21-2021
16:19:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/17/2021Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130976
Page 174 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-21-2021
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible and NOT c
onfirmed to have re
ceived only placebo
at Vaccination 1/2Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130977
Page 175 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-21-2021
16:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/17/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-21-2021
16:19:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130978
Page 176 of 178
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-28-2020
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-10-2020
15:17:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-10-2020
15:14:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-28-2020
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/28/2020Initial Entry
Aug-10-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130979
Page 177 of 178
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
15:17:30
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Aug/10/2020
Aug-10-2020
15:14:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/10/2020Initial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130980
Page 178 of 178
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail 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: 10071159 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020
07:58:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Click Here to EnableInitial Entry
090177e196ae402d\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130981